chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received from a health care professional on 03 November 2011. A 63-year-old female patient had received a FLUZONE intramuscular injection in left deltoid, lot number UH462AB on 26 October 2011. On 27 October 2011, the patient developed chest and sinus congestion, headache, fever, chills, cold symptoms and productive cough. In 2010, the patient had the similar symptoms but not as severe. No further information was available at the time of the report. The patient outcome was reported as unknown. Follow-up information was received from a healthcare professional on 17 January 2012. The reported stated that the symptoms in 2010 were the same as 2011, but not as severe. The patient has two daughters who are medical doctors (MD) and they both agreed on this reaction to the flu vaccine. The patient did not receive any corrective treatment by our doctors for the symptoms in 2010 and 2011. The patient outcome was reported as recovered/resolved on 02 November 2011. Follow-up information was received 19 March 2012 from a health care professional. The patient received an intramuscular injection of FLUZONE, lot number U3728AA prior to experiencing the same symptoms as the current event (but not as severe) in 2010. The reporter had no further additional information to provide. Documents held by sender: none.
Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on an unspecified date was vaccinated intramuscularly in the deltoid with a 0.5 mL dose of Pneumovax 23. Subsequently, on an unspecified date, the patient complained of injection site reactions. The patient sought unspecified medical attention. At the time of this report, the patient was recovering. No product quality complaint involved. Additional information has been requested.
On 4/15 at 1:50pm my injection arm started getting very itchy. I have a sore located 3 inches next to the injection site. Approximately 1 minute after it began to itch I got very hot and nauseous, approximately 30 seconds later I was unconscious and beginning to seize. I was unconscious for about 1 minute. When I awoke I couldn?t see anything, my entire body was numb and in pain. I couldn?t move my fingers. I was rushed to the ER but by the time I was seen I was fully coherent and fine.
No additional AE reported; The patient inadvertently received her second dose today, 06OCT2021./ Early administration of second dose; This spontaneous report has been received from a nurse practitioner, via a company representative, concerning a 20 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 23-SEP-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot number and expiration date were not provided), administered for prophylaxis.  On 06-OCT-2021, the patient inadvertently received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location, lot number and expiration date were not provided), administered for prophylaxis (inappropriate schedule of product administration). No additional information was known. No adverse event.
The pt experienced swelling in the right thigh 1-2 days post vax. Became red and hot. Was still walking had no fever, and was not acting ill. Treated with Tylenol, Motrin and Benadryl. Keflex was added on 4/23/00. Much improved on 4/24/00.
a female patient received the 1st dose on 05May2021, but missed the 2nd one; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (a female patient received the 1st dose on 05May2021, but missed the 2nd one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (a female patient received the 1st dose on 05May2021, but missed the 2nd one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a female patient received the 1st dose on 05May2021, but missed the 2nd one) outcome was unknown.        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.   No concomitant drug details were reported. No treatment details were reported.
Member reported "itching" to bilateral hands and feet.  Per observer RN; "couple bumps" to hand with itching to hand and legs. Member contacted 02/11/21; states all resolved.  States "took Benadryl" at home and "is fine."
Reactions from COVID vaccinations; flu like symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4429398-00 (AbbVie).  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (non-serious), outcome "recovered", described as "Reactions from COVID vaccinations"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms". The action taken for adalimumab was unknown.  Additional information: There was no reported medical history.It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The  reporter's causality for the event of REACTION FROM COVID VACCINATIONS with Pfizer biotech COVID-19 Vaccine (Tozinameran) was reported as probable. The reporter's causality for the event of REACTION FROM COVID VACCINATIONS with HUMIRA (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of FLU LIKE SYMPTOMS with HUMIRA was not provided.   Follow-up attempts are completed. No further information is expected.
No additional AE; The nurse reported the patient received improperly stored vaccines; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 08-MAR-2022, the patient was vaccinated with an improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot # U026664 and 1741817 has been verified to be a valid lot number rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 24-FEB-2023, and 30-JUL-2022 respectively) (strength, dose, route of administration and anatomical location were not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # U026217 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish as 02-NOV-2023).  The temperature of storage and time frame of the excursion were 34.3° Fahrenheit (C) for 55 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001816: US-009507513-2204USA001791:
Patient received wrong vaccination.  He is 14 years old and was given Janssen covid vaccine.  He should have gotten Pfizer.
This spontaneous report was received from a licensed practical nurse concerning an unspecified number of patients (ages and genders not specified) who reported that one dose of VARIVAX (Merck) and 10 doses of PROQUAD (Merck) that were improperly stored were administered to an unspecified number of patients. No adverse effects were reported. Follow up information has been received from licensed practical nurse via telephone call on 12-FEB-2015. Total number of doses administered of VARIVAX (Merck) was 13. On an unknown date 12 patients were vaccinated with improperly stored VARIVAX (Merck) (lot #K006136, expiry: 29-APR-2016). There was no need for revaccination. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Patient received Zostavax 11/5/13 woke up 11/6/13 with a stiff neck and neck pain and it has lasted 1 week.
Large swollen area developed 10 days after GARDASIL shot at the site of shot on her arm. Not red or warm. Mildly painful.
Twinrix has been given to a 14 year old; Twinrix / Instead of havrix and engerix b individually; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 29th March 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by the agency without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received Twinrix instead of Havrix and Engerix B individually at 14 years of age, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter asked what side effects should be expected and how to proceed with appropriate vaccination. The reporter consented to follow up.
This spontaneous report as received from a physician refers to a non-pregnant patient of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. On 10-DEC-2014 the patient was vaccinated with a dose of RECOMBIVAX HB (injection, lot # J014855, expiry date 16-APR-2016, 0.5 ml, intramuscular) post not supported temperature excursion. Patient didn't report any adverse effect. This is one of several reports received from the same source. Additional information has been requested.
Covid-19 Positive; low oxygen level; Chills; Headache; Fatigue; Redness; A spontaneous report was received from a consumer concerning a female patient of 79 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and tested positive for covid-19 and experienced low oxygen level, chills, headache, fatigue and redness.  The patients medical history was not provided.No relevant Concomitant medications were reported.  On 05 Feb 2021, prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 030L20A ) vaccine intramuscularly for prophylaxis of COVID-19 infection. On 06 Feb 2021, one day after vaccination, patient experienced chills, headache, fatigue and redness.  On an unknown date, patient experienced low oxygen level and tested positive for covid-19, patient was hospitalized. No Treatment information for the event was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events covid-19 positive, low oxygen level, chills, headache, fatigue and redness was not reported.; Reporter's Comments: Based on the current available information, the mRNA-1723 does not contain a virus and with the occurrence of a Covid-19 Positive test after vaccination, this event is as unlikely related to mRNA-1273. However,  the events of chills, headache, fatigue and redness are  possibly related to mRNA-1273 administered.
WHILE PATIENT WAS WAITING 15 MINUTES, HE STARTED LOSING FEELING IN HIS ARMS AND LEGS, NEXT HE LOST ALL STRENGTH IN ALL EXTREMITIES, STATED PAIN IN ARM AND SIDE OF RIB CAGE, STARTED LOSING VISION TO TUNNEL VISION AND BLURINESS. LIPS APPEARED SWELLING. WRITER CALLED 911 AND GAVE PATIENT EPI SHOT. EMT TOOK TO HOSPITAL
Back pain; Fatigue; Bitter taste in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Bitter taste in the mouth), BACK PAIN (Back pain) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L2OA) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DYSGEUSIA (Bitter taste in the mouth) and FATIGUE (Fatigue). On an unknown date, the patient experienced BACK PAIN (Back pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (Bitter taste in the mouth) and FATIGUE (Fatigue) had not resolved and BACK PAIN (Back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that she took Tylenol and ibuprofen for back pain. She thought that she was fatigued because of her heart. She spoke to her cardiologist and they have been running tests on her previously.
Patient stopped by pharmacy to receive/inquire about 2nd vaccine (SHINGRIX). I ask him how 1st vaccine went. He explained that a couple days later, noticed a penny size nodule on armpit. He also reported a splotch on chest and pimple like rash on torso. This resolved in a week.
4 hours after vaccine, felt like jaw locking. Jaw painful, hurt to move and couldn't open mouth much for 48 hours. Rapidly, the pain stopped 72 hours after vaccine and jaw felt fine. Prior tetanus vac. more than 10 years before.
pt recv vax 01SEP94 & that same day pt devel very watery, loose stools 4 to 5 times a day; This lasted for 3 months;
During a review of the internal records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
patient-reported feeling very ill x 2 days in bed with fever, chills, weakness   Then in May she suddenly became very confused, and started having weakness on the left side, jerking movements were also noted. She was admitted to a local hospital where she was visiting. She also had no control of her bladder and a Foley catheter was placed. She was discharged and then sent to a rehab for a few days and most of those symptoms have resolved. She still does not think her memory is quite right, and she has a lot of severe constipation and is going to see a gastroenterologist. Prior to this, she had been doing extremely well .
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 46 year old Hispanic or Latino male. The patient's height, and weight were not reported. The patient's past medical history included: was in previous car accident on 26-FEB-2020 which he now gets therapy for, and concurrent conditions included: hypertension, cocaine abuse (uses occasionally but its not an addiction), alcohol user (beer 2 weeks then he wont drink for 5 to 6 months), and cigarette smoker (10 cigarettes per day), and other pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 310017, and expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-AUG-2021, the patient had an appointment at the hospital because of previous car accident and did Covid test which came out positive (suspected covid-19 infection and suspected clinical vaccination failure). The reporter only notified the doctor where he goes and gets his therapy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210849124-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Itching all over, light red blotches all over. Took BENADRYL and put calamine on. Helped a lot. Still has symptoms and continuing BENADRYL.
Pt developed pain in right thigh/right knee about 3 hours after injection. Knee was painful to the point that pt would not bear weight by the following day. Had fever at home - not measured - thigh anteriorly and knee-very warm. Tender over knee. Edema of thigh and knee.
Fatigue, for about Two days afterwards. Diarrhea has persisted for four days afterward. Anxiety Disorder has been acting up, this could be from anxiety over the vaccine or a side effect of the vaccine. I?ve felt more anxious since I received my vaccine, not severely, just noticing more than a typical day. I?ve only received the first dose, if it happens more after the second I will file an additional report.
Dose 1 of Moderna was administered on 12/28/2020 and dose 2 of Moderna was administered on 1/22/2021. These were administered at a hospital.  We administered dose 1 of Pfizer on 7/5/2021 when we should not have administered anymore doses at all.  This was noticed today on 7/26/21 which would have been the time of dose 2 of Pfizer.  No issues reported.
Agitation, Headache, Abdominal cramps, pain at injection site Narrative: Patient received Covid vaccine on 12/27. Noted myalgias in the middle of the night. The following morning she awoke with abdominal cramps, headache, pain at injection site, tachycardia and anxiety. Seen in ED, given IV fluids and Rocephin.
Terrible joint pain in the right arm.  Received BOOSTER shot in right arm.  No problems with first two shots
This case was reported by a pharmacist via call center representative and described the occurrence of seizures in a 53-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020) for prophylaxis. The patient's past medical history included seizure. Concomitant products included gabapentin and valproic acid (Divalproex). On 29th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced seizures (serious criteria GSK medically significant and other: as per reporter). On an unknown date, the outcome of the seizures was unknown. The reporter considered the seizures to be unrelated to SHINGRIX. Additional information was received as follows: The concomitant drugs included anti depressant and anti anxiety medications. The health care professional (HCP) reported the patient had a pre-existing seizure condition since childhood that was controlled on divalproex.  After the patient experienced the seizures, the divalproex dose was adjusted and event was in control at the time of reporting. The reporter didn't feel that the vaccine caused the seizures to reoccur. The reporter did not have a too much information available. This was the information received from the pharmacy tech. The patient required emergency room visit. This was all the information available.
I went to get a pair of glasses and the doctor said that he suspected that I may have glaucoma. I went the next day to see another doctor who had the appropriate equipment to test further. He confirmed the glaucoma diagnosis. The official diagnosis was received on 10/12/2022. He prescribed a medication to lower the pressure within the eyeball. I have a follow up appointment with him in a few weeks.
Very severe migraine continuously for  four days. I checked my temperature the day after and had a fever of 99. I also have headache on and off almost every day for the last few weeks.  My arm was moderately sore for the first three days on and off but the pain wasn?t unbearable.
Developed increasing fever and arthritis (starting in ankles and progressing to knees) 3 days after vaccines peaking at 103 at about day 10.
Pt on way out of building mom noted hives and redness of (R) leg > (L) leg. No SOB, no cyanosis. Pulse ox 97- 100 HR 129- 135.
Temperature started to increase to 99.5 on 10/2/21 at 9:30am. Fever rose above 100 to 101 at 2:00pm. Chills started. Fever rose to 103.2 by 11:45pm on 10/2/21. Fever declined to 102 by 3am on 10/3/21. Fever decreased to 99.9 by 7am on 10/3/21 but fluctuated between 98.4 and 100 on 10/3/21. Fever stayed elevated bn 99 and 99.9 on 10/4/21. Fever decreased bn 98 and 99 on 10/5/21. Chills confined until 10/3/21 9am at which time, hot flashes occurred until 10/5/21. Body pain, headache, arm pain, swollen and painful lymph nodes of left arm pit occurred from 10/2/21 through 10/8/21. Woke up 10/8/21 with no symptoms except left arm injection site hurt to touch. Injection site was red and swollen from 10/2/21 to 10/5/21. Injection site was bruised 10/5/21 to 10/8/21. Treated symptoms with Tylenol, ibprofin, and ice pack. Sought medical care on 10/4/21 as still experienced symptoms. Dr said to start taking ibprofin and excused me from work for two days. Said to call back if symptoms still occurred after 10/6/21.
Rash; Bumps; Itching; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) (batch number EG55L, expiry date 7th December 2021) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 5H39T, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received Shingrix and Fluarix Quadrivalent 2019-2020 season. On an unknown date, couple of days after receiving Shingrix and Fluarix Quadrivalent 2019-2020 season, the patient experienced rash, swelling and pruritus. On an unknown date, the outcome of the rash, swelling and pruritus were recovered/resolved.   It was unknown if the reporter considered the rash, swelling and pruritus to be related to Shingrix and Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The batch number of Shingrix was updated as EG55L from  E655L as per sale's data sheet. On 4th December 2019, the pharmacist called regarding the patient received Shingrix and Fluarix vaccine on the same day, and few days after experienced rash, bumps and itching . The reporter stated that, symptoms took a week to go away. The reporter mentioned that the patient did not know if there were shingles.
Cold & hot sweats, fever, body aches less than 12 hours after the vaccination. This lasted 2 days. Since then, I have gotten my period twice monthly, I have been tired, achey. First time getting sick in 2+ years, no positive covid test, ongoing cough for 4+ weeks since 12/31.  Menstruation began again today 2/7/22 after complete 5 day cycle beginning 1/14/22.