chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to three male patients vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 25-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter (link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
PATIENT'S FIRST DOSE OF VACCINE WAS MODERNA. PFIZER WAS INADVERTENTLY ADMINISTERED IN ERROR
after first dose constant itch is completely gone; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (after first dose constant itch is completely gone) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Sleep problem, Itching all over (doctor called "senior itch") and Feeling abnormal (Miserable).    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (after first dose constant itch is completely gone). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (after first dose constant itch is completely gone) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 01-Mar-2021 patient took second dose in the right arm, batch number-011A21A. The patient confirms not experiencing any negative symptoms after receiving either dose. The patient reported that she constant itch completely resolved after receiving the first dose.   No concomitant medications information was reported.  No treatment details were provided.
Narrative:  Fully vaccinated COVID positive when presented to ED. Patient had mild symptoms of COVID and was sent home. Admitted to hospital 2 weeks later for AKI. No hx of prior COVID infections. Of note, patient was on chemotherapy during the point of testing positive and admission.
COUGH; SHORTNESS OF BREATH; SORE THROAT; DIZZY; CHILLS; HEADACHE; NAUSEA; FEVER; This spontaneous report received from a patient via a company representative concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced dizzy. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced sore throat. On 10-APR-2021, the subject experienced cough. On 10-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizzy, chills, and nausea on 10-APR-2021, and fever on APR-2021, and had not recovered from headache, sore throat, cough, and shortness of breath. This report was non-serious.
Participant had 3 minute seizure after receiving flu shot/ 911 was called/ participant taken to hospital.
About 5 hours after shot developed generalized arthralgias, headache, hot touch but no fever, chills. Severe leg and arm pain. Seen in ED @ hospital. Blood work (-). Thought viral.
pt recvd vax;5 episodes of paleness,dark lips & perspiration occured at 1:30pm & noc 9dec & 10am 10dec;recvd phenobarbital at  hosp on 10dec for prophylaxis of possible sz;
Shingles vaccine administered sub Q.    No adverse reactions noted at that time.  Follow up via phone call to patient 5/27/2021: Patient stated no adverse reactions noted except redness noted at injection site about 1 in.   Patient denies any pain, warmness or any signs of infection.  Follow up call made to patient 06/01/2021:  Patient stated only a very small dot of redness left, no signs of infection, pain, rash, itching, etc noted.
IN LEFT ARM: REDDNESS, SWELLING, PAIN, HOT TO TOUCH. ADVISED PATIENT TO APPLY COLD COMPRESS, TAKE IBUPROFEN AND IF ITCHING OCCURS TO TAKE BENADRYL, ADVISED IF NOT BETTER OR IS WORSE BY TOMORROW TO SEEK MEDICAL TREATMENT.
Dizziness, UrticariaPruritus & HYPERtension Narrative:
This case was reported by a nurse and described the occurrence of generalized rash in a 40-year-old female patient who received FLUARIX (batch number 45HX7, expiry date 30th June 2015). Previously administered products included flu vaccine with an associated reaction of no adverse event. On 5th November 2014, the patient received FLUARIX 1 ml. On 5th November 2014, an unknown time after receiving FLUARIX, the patient experienced generalize rash and pruritus. The patient was treated with BENADRYL. On an unknown date, the outcome of the generalized rash and pruritus were not recovered/not resolved. It was unknown if the reporter considered the generalized rash and pruritis to be related to FLUARIX. Additional information received: Nurse reports a patient received FLUARIX TIV on 11/5. After patient went home, she called the office stating  she now "is covered with itching and rash".
I received the second dose of the covid vaccine at about 6:30 on the 20th of January. On January the 21st at about 12:30 I started to get chills and a pounding headache, I then took my temperature again and it showed that I had a fever of 101. I went home from work and experienced the chills till about 5 in the evening and a fever until 9 the same night.
Twitching of muscles, sensation of vibration of legs, eyelids, other muscles. Subjective muscle weakness.  Follow up on 08/20/2003: "Immunization was given at local urgent care, not at office.  I don't have the requested information."
Sometime in the month of June, 2021, patient reported not feeling well in her stomach. Stomach pain off and on with lower abdominal pain bloating.  Put up with pain.  Thought it was "old age."   On  8/12/2021 patient had nausea, abdominal pain & vomiting aggravated by eating solid foods.  Losing weight.  Taken to local ER and was given stool softener & x-ray of abdomen.  Temp 98.2. Xarelto was prescribed, but patient couldn't take due to vomiting.    Severe pain now and persistent.   On 08/15/2021, patient was taken to different  ER for admission and work-up. Lump developed on back of head in October and as of February 11,2022, a new lump has appeared on patient's neck near carotid artery.  While hospitalized in ER, Xarelto prescribed and Rush enteroscopy procedure and stent placement performed.   Heparin drip for SMV thrombosis.   Partia bowel obstruction with abnormal thickening of the proximal jejunum causing obstruction of the distal duodenum.  Differential for jejunal lesion includes carcinoid lymphoma and small bowel adenocarcinoma.  Abnormally enlarged mesenteric lymph nodes.   For vaccines, patient had 2nd dose of Moderna injected into left arm the morning of May 7, 2021.  On December 3, 2021, patient had Moderna booster injected into left arm sometime in the morning hours.
Patient reports noting bilateral lower extremity swelling and redness that started after vaccine and has persisted.   He obtained care today at the clinic.  There are many other possible causes but reporting due to patients report this began after 2nd dose of vaccine.  No rash,  no itching
Information has been received from a physician concerning an 79 year old female who in approximately Sept 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647654/0865N). Post vaccination, the patient developed an injection site reaction which included upper arm swelling and redness that persisted for 5 days. Unspecified medical attention was sought. The patient was given unspecified antibiotics to treat an infection in case it is not just a local reaction. The patients outcome was not reported. The reporter stated that he would like an investigation into the lot to see if other problems were reported. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. It was also reported that a male patient (WAES0410USA00473) and another female patient (WAES0410USA01073) developed injection site reactions after vaccination with pneumococcal 23v polysaccharide vaccine from the same lot. Additional information has been requested.
Pt developed a rash and hives on trunk and legs early Saturday morning. She took a BENADRYL and went to ER. They determined she was having an allergic rxn but could not confirm it was to the vaccine. She was given BENADRYL, SOLU-MEDROL and ZANTAC and sent home. On 9/5 pt came into pharmacy and rash had cleared up.
Moderna 2/5/21, 3/5/21. Positive on 8/8/22
Hep-B vaccine give at 09:05 and at 09:15 pt had generalized flushing with mild tightness to chest. At 09:20, she had tingling of lips and puffy feeling of lower lip. She was given 50mg Benadryl, IM. Lungs were clear and BP and pulse was stable throughout. On 10:30, symptoms resolved and pt was transported home.
red rash; This case was reported by a pharmacist via sales rep and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. In August 2019, less than 6 months after receiving Shingrix, the patient experienced red rash. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by field reporter. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The patient got a red rash from Shingrix in the last 2 days. The reporter did not consent to follow-up. This case had been linked to the case US2019143171, reported by the same reporter.
Intense swelling  / Swelling under injection site; red under injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable. The reporter noticed that Shingrix tends to cause more intense swelling than other vaccines.  The only other vaccine reporter stated he sees this was with pneumovax. He stated red swelling under the injection site was common and that he had reported these events several times before but did not anymore.  He observed that it tends occur more often in patients who had prior history of herpes zoster and was wondering if there was any correlation.  No additional information was available to collect. The reporter consented to follow up.
a very large red, itchy histamine patch just below injection site; still visible today (3/10/21
First hoarseness with a cough. Then achy followed by a 102 temperature. Then very stuffy nose with red burning swollen eyes. I took Advil and now the next day all systems are gone except really swollen eyes.
This spontaneous report was received from the patient's aunt via a company representative, referring to her niece, a 13 year old female patient. On unknown dates, the patient was vaccinated with the 3 dose series of GARDASIL, for prophylaxis (dose, route, frequency, lot number and expiration date were not provided). On an unknown date, it was stated that the GARDASIL vaccine has stunted the patient's growth. Furthermore, it was reported that the doctor recommended hormone growth therapy to help with her height. At the time of reporting, the outcome of growth retardation was unknown. The reporter considered GARDASIL to be related with the event growth retardation. Nevertheless, it was also reported that the patient's doctor did not think that the stalling of the patient's growth was caused by GARDASIL. Upon internal review, the event growth retardation was determined to be a medically significant event. Additional information has been requested.
Frozen Shoulder from the Vaccine injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2022US228671_NS.  A 71-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: RECLAST. The following information was reported: PERIARTHRITIS (non-serious), outcome "unknown", described as "Frozen Shoulder from the Vaccine injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Her last Reclast infusion was in Oct2021, and then 10 days later had the Covid Vaccine injection. Consumer stated has gotten Frozen Shoulder from the Vaccine injection. Consumer's latest bone scan was lower then in the past. Consumer thinks the COVID-19 Vaccine injection was given too soon after having her Reclast Infusion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a physician concerning his 22 year old daughter who on 12-Mar-2009 was vaccinated with her first dose of GARDASIL (lot number and site not reported) 0.5ml IM. There was no concomitant medication. On 12-Mar-2009, after receiving the vaccine the patient experienced pain at the injection site and fainted. The patient also did not "feel well" for a few hours after vaccination. On 12-Mar-2009 the patient recovered from pain at the injection site, fainted and did not feel well. Pain at the injection site, fainted and did not feel well were considered to be disabling. Additional information has been requested.
One of her fingers in her right hand still feels a little stiff and numb; Feels tired sometimes; Drooping things when she tries to pick them up with her right hand; Right leg is weaker; Numbness in right side of mouth; Right hand is stiff; Gums are hurting on right side; Lower part of right arm near her hand feels cold; Problems with her teeth; Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPARESIS (Drooping things when she tries to pick them up with her right hand) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dental implantation in November 2020. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced HEMIPARESIS (Drooping things when she tries to pick them up with her right hand) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Right leg is weaker), HYPOAESTHESIA ORAL (Numbness in right side of mouth), MUSCULOSKELETAL STIFFNESS (Right hand is stiff), GINGIVAL PAIN (Gums are hurting on right side), FEELING COLD (Lower part of right arm near her hand feels cold), DENTAL DISCOMFORT (Problems with her teeth) and DIZZINESS (Lightheaded). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (One of her fingers in her right hand still feels a little stiff and numb) and FATIGUE (Feels tired sometimes). At the time of the report, HEMIPARESIS (Drooping things when she tries to pick them up with her right hand), MUSCULAR WEAKNESS (Right leg is weaker), HYPOAESTHESIA ORAL (Numbness in right side of mouth), MUSCULOSKELETAL STIFFNESS (Right hand is stiff), GINGIVAL PAIN (Gums are hurting on right side), FEELING COLD (Lower part of right arm near her hand feels cold), DENTAL DISCOMFORT (Problems with her teeth), DIZZINESS (Lightheaded), MUSCULOSKELETAL STIFFNESS (One of her fingers in her right hand still feels a little stiff and numb) and FATIGUE (Feels tired sometimes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included eye drops for Glaucoma, Blood pressure medicine, Antacid, Anxiety medicine that she hasn't started taking.  Patient's physician is aware and expects symptoms to pass.  Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Upon follow receipt: Added new AEs Numbness in right side of mouth, right hand is stiff, gumsare hurting on right side, lower part of right arm near her hand feels cold
Sore throat; 100.6°F fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), PYREXIA (100.6°F fever) and CHILLS (Chills) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 30-Mar-2021, the patient experienced CHILLS (Chills). On 06-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (100.6°F fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), PYREXIA (100.6°F fever) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Body temperature: 100.6 (Inconclusive) 100.6°F fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication  was provided.
10-14-14 at 5-6 pm note swelling, pain, redness, fever, nausea, vomiting, diarrhea. She reports reaction on 10-16-14 at 9:30 am. Note redden area (L) delt 7 x 6 1/2 cm warm to touch. She took ibuprofen - area marked BENADRYL given.
Patient presented to ED with chest pain/pressure two days after receiving second Moderna vaccination. Chest pain atypical for cardiac s/s, hypertension. Per Pt/family report vaccine was the trigger. Pt given GI cocktail. Cardiac workup negative, discharged home without escalation of care.