chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse via Evolution Marketing Research (reference # MRK30202) refers to a 12 year old healthy female patient. On an unknown ate the patient was vaccinated with a dose of GARASIL (lot# not reported) as HPV vaccination. On 08-MAR-2013 the patient experienced lightheadedness. There was none diagnostic tests carried out to diagnose the event. It was also reported that the event did not reappear after restarting suspected therapy. The outcome of lightheadedness was reported as recovered/resolved with sequelae. The relatedness of the event was unknown for GARDASIL. Additional information is not expected.
Patient received a dose of Pfizer vaccine. It was noted that the vaccine 5-day expiration date/time was 5/12/2021 at 930 am. Vaccine was administered to patient at 10:00 am on 5/12/2021. No adverse reactions noted during observation period. MD and management team aware.
9/3/08 - TC c/o low grade fever, rash to face, arms, upper chest, back, body aches x 3 days.  F/u with MD.
EXTREMELY inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth; EXTREMELY inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth; EXTREMELY inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth; vomiting; diarrhea; 10 pound weight loss in a week; Extreme fatigue.; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 09Apr2021 16:00 (at 72 years old, not pregnant) (Batch/Lot Number: ER8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included blood cholesterol, hypertension, both from an unknown date. The patient was taking unspecified concomitant medications. The patient had her first dose of bnt162b2 on 14Mar2021 16:00 at 72 years old for covid-19 immunisation, on left arm, lot number EP6955. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021, patient experienced extremely inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth, vomiting, diarrhea, 10 pound weight loss in a week, Extreme fatigue. No treatment received for the events. The outcome of the events was recovered on 2021. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known allergies.  Information on Lot/Batch number was available. Additional information has been requested.
Pt presented 4/25/06 with apparent erythema reaction to rt shoulder,previous MMR site. slight left arm erythema from Adacel injection. no s.o.b., has red border at site and along inner rt forearm, states no prior reaction. treated as reaction to MMR, prednisone rx given, allegra d daily,  given depomedrol 80 mgm im ruoq buttock, tol well. pt advised will recheck within 48 hrs if needed.
mid-July 2022 - Onset of right hand pain 8/24/2022 Appt with Dr - diagnosis osteoarthritis right thumb CMC metacarpal 10/26/2022 Follow-up appt with Dr - will need to manage condition
10 minutes after vaccination patient reported that she felt as though her face was swelling.  She was not in respiratory distress and had taken diphenhydramine earlier in the morning for possible reaction to a new medication taken the night before that she thought might have caused swelling on the right side of her face overnight.  Sent patient to ER across the street for evaluation. Patient did not want to be taken, wanted to drive herself.  Verified that she arrived safely at the ER.  Per patient report, swelling had not progressed and seemed to be stable.
Case number PHEH2014US017731, is an initial spontaneous report received from a nurse on 02 SEP 2014 and a follow up report from the nurse received on 03 OCT 2014, with a follow up report from the nurse received on 10 OCT 2014. This report refers to a adult female patient (in her 50's). She had no medical history. Concomitant medication was not reported. She tolerated FLUVIRIN well in the past. Nurse reported that the staff member erroneously gave the patient expired FLUVIRIN 2013/2014 (batch number 1307801) intradermally (instead of intramuscularly) on 02 SEP 2014 instead of a PPD (0.1 ml). They meant to give a PPD test. Nurse put some hydrocortisone on there because it was a little red. The nurse contacted in order to see if there were any side effects (symptoms/complications to be monitored. It was reported that the patient was doing fine and no adverse reactions were noted. The seriousness and causality assessment were not reported. The nurse asked to close the case. No additional details available.  Follow up report from the nurse received on 03 OCT 2014: Updated outcome of the event.   Follow up report from the nurse received 10 OCT 2014: updated vaccination history and reporter comment.
No adverse event; Patient received the vaccine from an expired lot; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot).    No concomitant medication information was reported. The patient age was reported as 35 Year 0 Month. Patients at the facility received vaccine between 08Apr2022 and 15Dec2022.  No treatment medication information was reported. NDC ID: 80777027399
This case involves a 77 years old female subjects who had therapeutic response unexpected after receiving the vaccine. No information was provided regarding previous therapies, premedication and concomitant medication, or if the subject presented events on previous vaccination. On an unspecified date, (latency unknown) after receiving a dose of FLUZONE HD (batch number, expiry date, dose, dose in series, route and site of administration were not reported) the subjects had therapeutic response unexpected after vaccination. It was reported that the subject have had the senior version and reacted poorly. No information regarding lab data and corrective treatment were reported. The outcome of the events was not reported. The event relation to the study vaccine or trial procedures: not reported. Relationship to investigational product according to Company: not associated. List of documents held by sender: none.
Major debilitative joint pain started in my right hip after I took the first shot. Then after the second shot, pain moved down to my ankle and moved back to my left hip and sacrum. Pain also moved to my right groin; which makes it very difficult for me to walk. I'm in severe pain when I walk, especially when I put weight on my right leg.
SUNDAY 3/26 - felt a little off but no symptoms in particular   MONDAY 3/27 - AM: woke feeling heavy and drained, low energy  - PM: skin SUPER sensitive all over body, mild chills  TUESDAY 3/28 - previous night?s sleep: woke 2-3x in full body sweat - All day severe back soreness  - AM: skin less but still sensitive, lower energy levels  - Afternoon walk: bad joint pain, especially in knees, low energy - PM: bad headache (took an Alka Seltzer), Epsom salt bath relieved some body aches and soreness  WEDNESDAY 3/29 - sleep: woke 2-3x in full body sweat  - AM: headache, mild joint pain, moderate back pain, in and out of periods of overheating and sweating (took an Alka Seltzer)  THURSDAY 3/30 - extremely tired, no energy - woke up with a lot of stiffness and pain in my left wrist   FRIDAY 3/31  - extremely tired, no energy - stiffness, though a bit improved, and pain in my left wrist  SATURDAY 4/1 - lethargic but a bit more energy  - wrist much improved  SUNDAY 4/2 - called off work  - AM: slept until 11:30-12p - PM: developed bad headache and the base of my head, my eyes were sensitive to light  MONDAY 4/3 - AM: woke up with stiff neck and headache at base of head, though not as severe as last night   TUESDAY 4/4 - Moderate stiffness in left wrist, limited ROM, improved throughout the day  WEDNESDAY 4/5 - SATURDAY 4/8 - light to moderate stiffness in left wrist  SUNDAY 4/9 - severe stiffness in L wrist, limited ROM, fluid-filled sac developed on the dorsal side (took ibuprofen, massaged), slightly increased ROM throughout day, difficulty putting weight on it but not particularly painful, more discomfort and limited mobility, limited grip strength  MONDAY 4/10 - no change in symptoms  TUESDAY 4/11 -no change in symptoms  WEDNESDAY 4/12 - stiffness and pain much improved, increased ROM - Visited urgent care   THURSDAY 4/13 - nearly all wrist pain, swelling, and stiffness went away   Residual symptoms include some knee
2mo old LAM who developed irritability & screaming approx 3-4 hrs p/vax; cried for several hrs; could not be consoled; had subjective fever; episode resolved by following morning;
Developed scratchy throat, ached all over, lethargy, fatigue & nausea; Vaccinated w/2nd dose sx recurred but were more severe;
This spontaneous report as received from the patient's mother refers to her 15 year old son with no drug reactions or allergies and not medical history. In June 2014, the patient was vaccinated with the first dose of GARDASIL and in August 2014, was vaccinated with the second dose of GARDASIL, (lot number, expiration date, route and dose were reported for both doses). In late February 2015, the patient was vaccinated with the third dose of GARDASIL (Lot number, expiration date, dose and route were not reported). Although the patient's mother was not aware if GARDASIL or GARDASIL 9 was administered as third dose. There was no concomitant therapy. The reporter was not aware if the third dose of GARDASIL received was GARDASIL or GARDASIL 9. The patient's mother reported that the patient experienced a rash on his left hand, within May 2015 reported as "within past month", that came and went intermittently. she also reported that in June 2015 reported as "most recently, in the past few days" the patient experienced urticaria reported as "hives" on his back and chest, which were worse, in the evening, on two occasions. On 09-JUN-2015, the patient consulted the physician, who advised him to see an allergist. The physician provided to the reporter with the patient product information for GARDASIL. No laboratory diagnostics studies were performed. The patient's urticaria and rash were reported as resolved on 09-JUN-2015, after receiving BENADRYL as treatment. The outcome of interchange of vaccine products was unknown. The reporter did not assess the relatedness of GARDASIL to rash, urticaria and interchange of vaccine products. Additional information has been requested.
some inner ear itching; face felt itchy but looked normal; achy here and there; nose felt hot; lips swelled up; Bilateral thighs felt a pulling sensation, upper and lower; bad headache; tired; had some tongue swelling and blistering/swelling; had some tongue swelling and blistering; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Within 2 hours the patient had some tongue swelling and blistering, which all subsided after 24 hours. The patient still had a lingering sensation but the swelling subsided. Some inner ear itching and her face felt itchy but looked normal. The patient was tired the next day, which could 've been the benedryl and achy here and there. The patient stated no flulike symptoms. Then on Friday at 6:30pm her nose felt hot and her lips swelled up.  Bilateral thighs felt a pulling sensation, upper and lower, and then a bad headache all day yesterday. The outcome of event tongue swelling and blistering was recovered, the others was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 26-year-old male. Neither medical history nor concomitant medications were reported. On 20-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
4" x 3" superficial area of mild erythema to (L) upper arm. Plus warmth; no streaking or extreme tenderness.
Information has been received from a consumer concerning the 14 year old daughter with no pertinent medical history and no drug allergies, who was vaccinated with MMR II when she was younger. There was no concomitant medication. She received other unspecified shots later on. The patient was delayed in everything after the vaccination of MMR II. She showed all types of autism when she was younger. The mother mentioned that at her daughter's 2 month shots (unspecified), the patient ran a fever and was irritable. Few other shots (unspecified) later on, the patient stopped smiling and made no eye contact. The patient was a happy and smiley baby and then would not smile. The mother felt as her daughter received more shots, she changed more and more. By the age of 3, the patient was only saying 30 words. The mother stated "My daughter is doing better but her personality is different. Everyone in my family is outgoing and my daughter is outgoing but not in the same way. My daughter takes everything literally so you have to watch you don't use the wrong words, for example if you told her to put the watermelon in the freezer, she would put it in the freezer,even though this is incorrect." Labs and diagnostic tests included hearing test and "a lot of different tests". The patient visited office for medical attention. At the time of the report, the patient's status was unknown. Upon internal review, autism was considered to be an other important medical event. No further information is available.
R sided facial palsy No evidence of shingles and no evidence or hx HSV-1
COVID infection, fever, headache, congestion, cough, fatigue, bronchitis; started July 10, tested positive for COVID on 7-14-2021; began OTC Tx with Aleve, Mucinex DM on 7-10-2021; telehealth visit on 7-15, prescription albuterol, prednisone 20 mg tablet 2 tablets daily; bromphen-pse-dm 2-30-10 mg/5 mL, 10 mL every 4 hours; sulfamethoxazol-E-TMP DS tablet mg bid
pt recv vax OCT96 & devel a h/a;this is one of five cases reported by a RN;cross reference to 0010150960144 to 0010150960147
Redness at injection site, itching, fever, throat swelling, breathing difficulty, dizziness, flushing, swelling of face.
This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Lightheadedness) and FEELING ABNORMAL (It is still sore, know exactly where receive the shot, can feel it exactly) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 039C21A) for COVID-19 vaccination. No Medical History information was reported.On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (Lightheadedness) and FEELING ABNORMAL (It is still sore, know exactly where receive the shot, can feel it exactly). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Lightheadedness) and FEELING ABNORMAL (It is still sore, know exactly where receive the shot, can feel it exactly) had not resolved. Concomitant product use was not provided. Treatment information was not  provided. Patient received both doses of the Moderna COVID-19 Vaccine and called to report a sore arm still today and a lightheadedness that is ongoing.The patient said that thought the lightheadedness was going to pass but has been going on. The symptoms started between 4 to 6 days after the second dose and have been having it since. He is going to see the doctor next Friday.
This spontaneous report was received from a physician via a company representative and refers to a 65 year old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On approximately 03-OCT-2017, reported as 2 weeks ago, the patient was vaccinated with PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On unknown date in October 2017, after receiving PNEUMOVAX 23, the patient experienced general muscle aches. The patient had no fever. The outcome of the event was reported as recovered/resolved on an unknown date in October 2017, as the patient was fine at the time of reporting. The relatedness between the general muscle aches and the suspect drug was not reported.
Rash, swelling, eruptions and itching on head, neck underarms, hands, feet and groin area. Went to ER at 2am and left at 8am. On 11/30/2001, IV given antihistamine, antibiotic, saline and glucose.
Second shot, cold light temp, diarrhea, injection site pain, arthritic knee hurt badly- felt fuzzy and lightheaded for everyday since shot. Added 5/7 some days super duper tired  Pfizer 03/13/ 2021 left arm.  No medicine, has arthritis,
No additional adverse effects reported; An unspecified amount of improperly stored doses of PROQUAD and VARIVAX were administered; This non-valid spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' concurrent conditions, medical history, historical drugs,drug reactions/allergies and concomitant medications were not provided.   Since an unknown date in February 2020, an unspecified amount of patients were vaccinated with an unknown improperly stored doses of Measles, Mumps, Rubella and Varicella Virus Vaccine Live (PROQUAD) (dosage regimen and route of administration not provided), lot# S021622, expiration date 09-JAN-2021; and with varicella virus vaccine live (VARIVAX) (dosage regimen and route of administration not provided), lot # S021924,expiration date 15-JUL-2021, given as prophylaxis.  All the lot# involved experienced a range of temperature between 6 Fahrenheit (°F) to 14 °F (average temperature of 13 °F) for 40 minutes. The vaccines did not have any previous temperature excursion. The call was placed due to a digital data logger. No additional adverse effects reported.  This is a non-valid case due to lack of patient identifiers.
Within 18 hours-swelling 2"x3" raised 1/2-3/4 inch, hot, have been-icing/heat pack-5th day=still swollen, very tender and hot-very uncomfortable.
I have all possible side effects; I believe I have got covid-19; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (I have all possible side effects) and COVID-19 (I believe I have got covid-19) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (I have all possible side effects) and COVID-19 (I believe I have got covid-19). At the time of the report, ADVERSE REACTION (I have all possible side effects) and COVID-19 (I believe I have got covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided.   This case was linked to MOD-2021-223973 (Patient Link).   Reporter did not allow further contact
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Feb2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 31Jan2023 to 05Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID  19 and BNT162B2.