chrisvoncsefalvay/vaers-outcomes huggingface dataset:
59 y/o female presents for vaccination. Patient brought to exam room 1. Name and DOB verified. Asked patient, ?Is this your first dose of the vaccine?? Patient replies,? yes.?  Began educating patient about Pfizer vaccine, possible side effects of vaccine, when to return for the second dose, and instructions related to remaining in the clinic area for 15 minutes post immunization. Patient states, ?I need help scheduling my second dose.? Informed patient that second dose was automatically scheduled when first appointment was made for vaccine. Patient stated she didn?t think so. I informed patient that it was included in her confirmation email, but that following her appointment today, we would confirm that. Patient agreed. Pfizer dose 0.3ml given in right deltoid. Immediately following immunization, patient then states, ?I wanted the shingles vaccine.? There was no verbal mention of this prior to immunizing patient. Patient did fill out vaccine form requesting shingles vaccine, but check marked box was very faint and this NP did not notice the box. When stating ?first dose,? could have been for shingles or covid; this NP did not specifically verify.  Patient informed that she was given Pfizer vaccine instead of shingles vaccine. Patient stated she had already had two doses of Pfizer ?at the beginning of the year.? Asked patient to wait 14 days and then return for shingles vaccine at that time. Patient agreed. Patient tolerated vaccine without complaint. Patient was not concerned about receiving a third dose at this time. Stated she understood it was an accident. Had patient wait in clinic area for 30 minutes. No adverse effects noted. Patient stated she felt fine. Walked patient to her car. Asked patient to call clinic to let staff know she made it home ok. Patient called clinic and stated she was home, feeling fine and thanked clinic for concern.
tendinitis in right shoulder and swollen lymph nodes in right shoulder and neck.  Pain from tendinitis began ~12 days after second injection
pt started to cry as soon as got home & cont to cry-inconsolably for 24 hrs; no fever also had large red swollen tender area @ site of inject;
Patient described arm as immediately very sore on day of vaccination, with notable adverse reactions several days (3 days) later of itching, redness, swelling and tenderness. Patient MD has advised diphenhydramine to treat reaction starting today.
A few days after the vaccine I woke up with a headache and chest pain.  The headache was like none I had ever had before. I went to the hospital for treatment and stayed overnight.
A 30-year-old female was vaccinated with GARDASIL 9 and she had a lack of effect from the product. / She had undergone "4-5 procedures for VIN".; A 30-year-old female was vaccinated with GARDASIL 9 and she had a lack of effect from the product. / She had undergone "4-5 procedures for VIN".; This spontaneous report was received from a pharmacist  and refers to her coworker who is a currently 30-year-old female patient. Her concurrent conditions, medical history and concomitant therapies were not provided.   On an unknown date (in appropriate age when the patient was an adolescent), she was vaccinated with HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), intramuscularly (strength, dose, frequency, lot number and expiration date were not reported) as prophylaxis.  The patient reported that she had a lack of effect from the vaccine since on an unspecified date, she experienced vulval intraepithelial neoplasia (VIN) and she sought medical attention. She had undergone 4-5 procedures for the VIN. It was unknow if any lab diagnostics or studies were performed. The outcome of the lack of effect from the vaccine and vulval intraepithelial neoplasia was reported as not recovered.  The causality between the events and HPV rl1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, vulval intraepithelial neoplasia was considered to be a medically significant event.
RESTORED HEARING; UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included neural hearing loss. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 23-JUN-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced restored hearing, and unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the restored hearing and unexpected therapeutic benefit was not reported. This report was non-serious.
none, patient recieved pfizer booster shot that was in fridge after beyond use date by 3 days
Huge red welt at injection site that has continued to grow larger 2 days later. Hot to touch and starting to itch 2 days later. Nausea for 2 days that has now started to subside. Low grade fever. Fatigue. Brain fog. Minor congestion. Sever sever headache primarily behind both eyes constant.
Quarter size swelling at site with pain, redness and itching which increased slightly over the course of a few hours and gradually receded. No medical treatment sought.
Visual Hallucinations (Hubble telescope stars and face in stars), inability to sleep, finger joint pain, toe pain, teeth pain, headache, chills and low body temp 97.1  Followed by 99.7 temp.  It felt like I was dying and trapped in a nightmare or drug trip. (I have never done acid but I strongly believe that this is what a bad trip would have felt like)
Symptoms for 10 days (March 2 - March 11, 2021): nausea, fatigue, headache, chills Symptoms for March 2: nausea, fatigue, headache, chills, vomiting, and diarrhea (vomiting for one day, diarrhea for 2) Symptoms for March 3: nausea, fatigue, headache, chills, diarrhea
Severe muscle pain, flu like symptoms, fever, nausea, vomiting, joint pain, inability to function that day.
Increased of fatigue that I already had from dose 1, increase of muscle aches and headaches for 4 days (I was still experiencing those with vaccine dose 1). Tested covid positive on 01/03.
Vertigo, dizziness, trouble walking, getting up from bed. Gets better as the day goes on, but wake up and it's pretty intense. Heavy head in the morning, and definite vertigo. Being treated in the past for BPPV (Vertigo).  This is more severe, and I dont know if the vaccine could of triggered it.
right-chest wall shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 20-AUG-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date in 2012 (reported as shortly after vaccination), the patient suffered a bad case of right-chest wall shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using vaccine. The patient also experience mental and emotional distress due to resulting physical limitations and seriousness of patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The reporter considered bad case of right-chest wall shingles to be related to zoster vaccine live (ZOSTAVAX). The event of sudden bad case of right-chest wall shingles was considered to be disabling.
PER PATIENT MOTHER HAD REACTIONS TO HEP B WHICH INCLUDED SWELLING/RASH TO BILATER LOWER EXTREMITIES AND LOWER ABDOMEN GIVEN AT ANOTHER FACILITY.  ROTATEQ GIVEN PO  ON 01/17/2014 1ST DOSE SERIES PER PATIENT MOTHER STATES CAUSED BOWEL ISSUES AND PATIENT HAD TO BE SEEN IN THE ER
Aside from general standard reaction of mild flu like symptoms, new and outstanding reaction was excruciating abdominal pain throughout the entire intestines.  Pain was so bad I almost went to the ER expecting to find bowel perforations. Over-the-counter painkillers would not touch the pain but tramadol helped.  Pain lasted for a day and in the second day began to ease off.  Bowel movements shifted in color immediately from standard color to a light and bright yellowish orange.  Self-treated with NAC and turmeric, and physical therapist used manual modality on the blood flow to the gallbladder which was indicated by specific pain points in the Strain -Counter-Strain modality.  Bowel movements returned to normal color after approximately 1 week (the day after physical therapy treatment).
48 hrs......100 degree temperature, sore arm, headache, muscle/joint aches, fatique
pt states she developed severe dry mouth.  About 12 hours later her heart started racing which lasted about 12-14 hours.  She developed 101 fever.  Her fever lasted about 36 hours.  Her lymph node was very swollen under her left armpit.  It was painful  so she was not able to put her arm down for about 12 hours.  These symptoms lasted several days and she no longer has any symptoms.
Fever - headache - body aches - red - hot swollen arm. Administered 2/20/12 went to ER 2/22/12 seen in MD office 2/23/12. Reaction started 2/21 - swelling, pain, redness, then fever, myalgias, HA.
Enlarged, painful lymphoma in the armpit on the side of the body that got the injection.
back pain; trouble walking; Had a severe, severe, severe muscle pain across her back and is on going; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), GAIT DISTURBANCE (trouble walking) and MYALGIA (Had a severe, severe, severe muscle pain across her back and is on going) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21a, 003A21A and 031L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLULAVAL QUADRIVALENT and SHINGRIX. Concurrent medical conditions included Blood pressure high (not sure when first diagnosed.), Reflux gastritis, Penicillin allergy and Drug allergy (Septra). Concomitant products included LISINOPRIL for Blood pressure high, PANTOPRAZOLE SODIUM for Gastroesophageal reflux.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced BACK PAIN (back pain), GAIT DISTURBANCE (trouble walking) and MYALGIA (Had a severe, severe, severe muscle pain across her back and is on going). The patient was treated with PARACETAMOL (TYLENOL A) for Pain, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (back pain), GAIT DISTURBANCE (trouble walking) and MYALGIA (Had a severe, severe, severe muscle pain across her back and is on going) had not resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-161898, US-MODERNATX, INC.-MOD-2021-161897 (E2B Linked Report). This case was linked to MOD-2021-377102 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Significant follow up received (information regarding seriousness, concomitant and treatment medication included).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-161898:(No subject)  US-MODERNATX, INC.-MOD-2021-161897:
No additional AE/PQC reported.; two patients received expired MMR II vaccine; two patients received expired MMR II vaccine when they were supposed to receive a dose of PROQUAD; This spontaneous report has been received from an other healthcare professional (nurse) referring to patient with unknown gender and age. The patient's concomitant therapies, medical histories and drug allergies were not reported.   On 20-JUL-2023, the patient was vaccinated with expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (albumin status recombinant human albumin (rHA)) (M-M-R II) subcutaneous injection, 1 dose, lot # U022316, expiration date: 15-JUL -2023, as prophylaxis (strength and route of administration was not specified), when the patient was supposed to receive a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)(fomulation, strength, dose, frequency, lot #, expiry date, indication and route of administration were not provided, the product was not administered) (Expired product administered) (Wrong product administered). No further information available during interaction. No additional adverse events (AEs) were reported (no adverse event), and no product quality complaints (PQCs) were reported.    This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA011317:
pt came to the site for vaccination. verified pt name, dob, and  allergies. pt counseled on possible side effects. vaccine administered. pt  felt vertigo after MCV vaccine administered. waited a couple of minutes before  vaccinating with HPV. pt stayed for observation and released. pt left in  stable condition.    BP 95/65
Vaccine was administered. Approximately 5 minutes later patient complained of temporary vision loss and ringing of ears. Had patient sit down and gave water. Patient complained of feeling cold, but vision had improved and he never lost consciousness.
Side effects on the third Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects on the third Moderna booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects on the third Moderna booster). At the time of the report, VACCINATION COMPLICATION (Side effects on the third Moderna booster) outcome was unknown.  No concomitant medications were reported.No treatment medications were reported.
Stomach cramping/like labor pain or punching from the inside; This case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes mellitus, blood pressure high and blood cholesterol increased. Concomitant products included antihypertensives nos (High Blood Pressure Medication (Nos)), medication unknown (Cholesterol Meds (Medication Unknown)) and semaglutide (Ozempic).   On 7th October 2022, the patient received the 1st dose of Shingrix (intramuscular). On 7th October 2022, less than a day after receiving Shingrix, the patient experienced stomach cramps. On an unknown date, the outcome of the stomach cramps was not recovered/not resolved.   It was unknown if the reporter considered the stomach cramps to be related to Shingrix.     Additional Information: GSK receipt date: 14-OCT--2022 Reporters comment:  The patient received the first dose of shingrix and experienced stomach cramping that was last about a week she also described that was like labor pain or punching from the inside The patient took medications for HBP, Cholesterol and Ozempic The reporter declined to provide demographics customer states that she did not have a PCP The consent was not requested .
Right back of arm on subcutaneous area has oval, 5x15cm, red rash. No satellite lesions. Indurated to palpitation. No warmth, swelling of arm, streaking or bruising. Denies SOB, wheezing or throat closing.
Extremely heaving periods. Bleeding went from light for 4-5 days to bleeding heavy for 14+ days; Cycle went from 29 days normally to 44 days.; Cramping is bad; This is a spontaneous report from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.   A 31year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Aug2021 at 13:00 (Lot number: FC3180) at the age of 31 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EW0198, Anatomical location: Left arm, Administration Time: 13:00, Route of administration: Unspecified), administration date: 26Jul2021, when the patient was 31 years old, for COVID-19 immunisation.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 04Sep2021 at 13:00, outcome "not recovered", described as "Extremely heaving periods. Bleeding went from light for 4-5 days to bleeding heavy for 14+ days"; OLIGOMENORRHOEA (non-serious) with onset 04Sep2021 at 13:00, outcome "not recovered", described as "Cycle went from 29 days normally to 44 days"; DYSMENORRHOEA (non-serious) with onset 04Sep2021 at 13:00, outcome "not recovered", described as "Cramping is bad". The events "Extremely heaving periods. Bleeding went from light for 4-5 days to bleeding heavy for 14+ days", "Cycle went from 29 days normally to 44 days." and "Cramping is bad" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of heavy menstrual bleeding, oligomenorrhoea and dysmenorrhoea. Additional Information: The patient did not receive other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/ clinic visit.   No follow-up attempts are possible. No further information is expected.
Patient reported that he is having a hard time/discomfort raising his left arm when the vaccination was administered and having a soreness at the site of injection.
1 week later large red spot around injection site and rash and then 9 days after injection full body rash
Aches; Headache; Tired/fatigued; Sleepy; This is a spontaneous report from a contactable consumer. An adult non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 09Mar2021 as a single dose for COVID-19 immunisation. It was unknown if the patient had any medical history. It was unknown if the patient had known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had received any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Mar2021, the day after the vaccine, the patient experienced aches and headache which minimized during the day. On the same day, the patient also experienced tired, sleepy and fatigued. The patient was feeling much better on the second day after the shot. The patient had no aches and had "normal" tired feeling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events aches, headache, tired, sleepy and fatigued were resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age. On an unspecified date, the patients were vaccinated with a dose of VARIVAX (Merck) lot # (670338/0467AA, exp date 31-MAR-2012) (dose and route not reported). It was reported that VARIVAX (Merck) vials had been stored at temperatures ranging 6-8 F for unspecified among of time since receiving the vaccine and some doses were administered to the patient. There were no adverse effects reported. Additional information is not expected.
This patient had DTaP, IPV, and Comvax given on 12/14/00. By 12/16/00, the DTaP site was red, swollen, and tender. The patient afebrile. The child was started on Cephalaxin as a precaution. The area is 6 x 7 cm in size. On 12/18/00 the patient was improving.
Whole upper arm is swollen, very large red area that is hot to touch. Arm is very sore/painful. Fever of 100.6
Started to experience anxiety and dizziness approx 1 hour after receiving vaccine. BP elevated at time of observation (168/102). Obesrvation time extended to 1.5 hours. Provided hydration and light meal. Discharged per team member request after she stated she felt better. Encouraged to take BP meds as directed per PCP.  Encouraged to go to ER for symptom return or additional adverse reactions per handout/Agency guidelines.
Patient states are very swollen with red mark that has increased to golf ball size swelling.  Reports swollen lymph nodes in the arm and tingling down arm
pain in the administration site; tired; feeling dehydrated; had a low degree fever; her nostrils were stuffed or clogged.; pain in the arm; went to sleep 3 hours earlier than usually did, waking up five hour later; feeling like that was about to had flu; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 2 patients. This is 1st of 2 reports. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid 19 vaccination. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2. The patient reported that she experienced a few symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. The consumer reported that she was in observation for 30 minutes after she was administered with the second dose of the Pfizer's COVID-19 vaccine and she felt only pain in the administration site. Then at night she felt really tired and she went to sleep 3 hours earlier than she usually does, waking up five hour later with pain in the arm and feeling dehydrated and with the need of sugar, also feeling like she was about to had flu. The patient measured her temperature and she reported that she had a low degree fever but maybe the thermometer was malfunctioning, also she noticed that her nostrils were stuffed or clogged. The consumer reported that today on 29Dec2020 in the morning she woke up feeling much better and with one nostril unclogged. The consumer reported that the same symptoms were experienced by a friend of hers after the administration of the second dose of the Pfizer's COVID-19 vaccine. The outcome of the events was recovering.  Information on the lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020519005 same reporter and drug and AE, different patient;US-PFIZER INC-2020519005 Same Reporter and Drug/Diffrent Patient