chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning a 71 year old female with a history of osteoporosis and no allergies, who on 30-NOV-2005 was vaccinated with a 0.5 ml intramuscular dose of pneumococcal 23v polysaccharide vaccine (Lot#651318/1006P).  Concomitant therapy included alendronate sodium (MSD), calcium (unspecified), vitamin D (unspecified), simvastin (MSD), and folic acid.  On 01-DEC-2005 the patient's arm, at the injection site, became red, warm, painful, and swollen.  She also had a fever to 101 degrees F.  The patient called the physician who recommended rest.  It was reported that the patient was improving.  Follow up information has been received from a physician concerning the 71 year old retired white female patient.  It was reported that on 30-NOV-2005 she had a severe local reaction with arm swelling and 100 degree oral temperature, and that she requires 1 and a half days bed rest before recovering on 02-DEC-2005. No product quality complaint was involved.  No further information is available.
An 11 year old patient received 0.25mL of the Moderna vaccine instead of the Pfizer vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 11 year old patient received 0.25mL of the Moderna vaccine instead of the Pfizer vaccine.) in an 11-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00721A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 11 year old patient received 0.25mL of the Moderna vaccine instead of the Pfizer vaccine.). On 17-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (An 11 year old patient received 0.25mL of the Moderna vaccine instead of the Pfizer vaccine.) had resolved.      No relevant concomitant medications was reported. Treatment information was not provided.
From info received at manufacturer on 12/02/2002, it was reported by the 42-year-old female pt that a stray cat bit her on 11/02/2002. She received a post-exposure series starting on 11/05/2002, she received Rabies Immune Globulin and 5 doses of Imovax Rabies, lot number U0971-3l She stated that she experienced vomiting and diarrhea continuously since first dose. After the third dose she had a high fever and a heat rash. Pt recovery status is unknown.
Patient received a dose of Pfizer COVID-19 Vaccine Peds formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9%NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.
Few scattered vesicular lesions on forearm and face. No systemic symptoms except fatigue. Major reaction at site of vaccina vaccination, left arm.
Patient was given the Moderna vaccine in error, because she is only 14 years of age. Patient has not experienced any symptoms or adverse reaction outside of the normal pain at the injection point and upper arm area.
Crying, fussy, will sit. He was found to have a rectal temp of 105. He was given TYLENOL and MOTRIN, and had blood and urine cultures sent. An LP was performed because of his fussiness and age, which is negative for infection. His fever has defervesced and he has eaten well here. ED Diagnosis: Febrile seizure; simple. Upper respiratory infection. Additional diagnosis: Prematurity
Pt recv vax on 9/3/98; on 9/11/98 pt exp fussy, low grade temp; 9/12/98 rash starting on face, 9/14 rash spread to trunk.  Temp lasted for 3 dys.
Pt received Tdap-in (R) arm. Next day developed swelling & redness. At visit 9 days later, swelling resolved but still some erythema of upper arm.
Soreness at injection sight. High Fever the next day. Sever pain in joints the next day. Headache and nausea the next day.
Diagnosed with Charcot Foot; Leg edema; Leg huge from knee down after 2nd dose; Leg hot after 2nd dose; Right foot swelling after 2nd dose; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Mar-2021. The most recent information was received on 26-May-2021 and was forwarded to Moderna on 26-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEUROPATHIC ARTHROPATHY (Diagnosed with Charcot Foot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient's medical history included No Adverse event.  Concomitant products included ATORVASTATIN for Product used for unknown indication, SPIRONOLACTONE, PARACETAMOL (TYLENOL ARTHRITIS), ALLOPURINOL, DULOXETINE, LEVOTHYROXINE and PREGABALIN for an unknown indication.   On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right foot swelling after 2nd dose). On 12-Mar-2021, the patient experienced JOINT SWELLING (Leg huge from knee down after 2nd dose) and FEELING HOT (Leg hot after 2nd dose). On 05-May-2021, the patient experienced NEUROPATHIC ARTHROPATHY (Diagnosed with Charcot Foot) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (Leg edema). At the time of the report, NEUROPATHIC ARTHROPATHY (Diagnosed with Charcot Foot), PERIPHERAL SWELLING (Right foot swelling after 2nd dose), JOINT SWELLING (Leg huge from knee down after 2nd dose), FEELING HOT (Leg hot after 2nd dose) and OEDEMA PERIPHERAL (Leg edema) outcome was unknown.            No treatment information was provided. Patient informed that inflammation of feet was not related to Moderna vaccine.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26 May 2021, upgraded the case to serious with the addition of new events Charcot foot and neuropathy.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
"HAIR LOSS,AND IRREGULAR MENSES,JOINT PAIN, HEADACHES ETC: Our daughter, who had completed her series of 3 vaccinations of "Gardisil" has been experiencing considerable hair loss.  Her first shot was in May 24, 2007, the second on July 26, 2007 and the third and final on November 27, 2007. Here are the other specifics....our daughter was 13 turning fourteen. She has had every blood test imaginable to rule out the obvious which may cause hair loss such as thyroid disease, polycystic ovary disease, diabetes, and the list goes on and on. Everything came back negative.  We even have a future appointment scheduled with a rheumatologist this coming November 08.  We have seen the Endocrinologist and two dermatologists (a scalp biopsy proved negative to any infection, disease, etc.  Granted, she had a typical amount of stress during the school year, as any young teen would, but nothing to cause this.  Everyday our daughter says to us, "you should see how much hair fell out in the shower today". She's so afraid to brush or comb it because of the extreme shedding. She literally, to date has half the amount of hair she had one year ago.  Let me tell you she had beautiful hair.  The hair loss is becoming quite visible at the forward part of her scalp.  This has been devastating, hair is everything to a teen. (to anyone this is devastating) We must also mention that her periods have been totally out of whack.  She went 6 months at one point without one.  It finally came back, but it is so sporadic, getting every two weeks, at times extremely heavy, etc... She also complains of intermitent dizziness.
This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a 62-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included cold sores (cold sores in eyes and in nasal passages, about 30 years). In July 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX, the patient experienced unexpected therapeutic effect. On an unknown date, the outcome of the unexpected therapeutic effect was unknown. It was unknown if the reporter considered the unexpected therapeutic effect to be related to SHINGRIX. Additional information received as follows: The patient was never treated for cold sores. The patient noticed a great reduction in episodes with the last being about 3 weeks prior to his 2nd dose of SHINGRIX which was received in mid of November 2018. He did not have anymore cold sores in his eyes or nasal passages. The patient felt GlaxoSmithKline ought to know about this.
Patient called.  She reports swelling, redness, and pain in the arm that the injection was given. She has been applying ice to the injection site. I recommended she be seen locally for assessment.
Swelling rash on arms, knees, feet lasted 5 day with no treatment.
Initial case received 19 February 2010 from a physician (is also the patient). A 55 year old male patient with a medical history of hypertension and chronic urticaria with infrequent angioedema, received an injection (route and site not reported) of ADACEL (lot number C2889AA) on 29 January 2010. Immediately following vaccination the patient experienced injection site tenderness. Within a couple of days he experienced injection site swelling, shaking, chills, night sweats, joint tenderness and muscle tenderness. Then over the next week he experienced fatigue, headaches, increased night sweats, increased joint soreness and increased muscle soreness. He had a temperature ranging to "102." On an unspecified date following vaccination, the patient's pre-existing chronic urticaria with infrequent angioedema worsened. Concomitant medications included LIPITOR, ASA, MODURETIC and vitamin B 1000IU. He had no known allergies and had no illness at the time of vaccination. On an unspecified date the patient (physician) was seen by another physician, lab work showed an elevated sed rate of 64 and blood in urine. On an unspecified date, the patient reported that he had stopped taking LIPITOR 2 weeks ago (approximate date 05 February 2010). He was using TYLENOL and ibuprofen. At the time of this report the patient stated he felt the symptoms were improving, but still had body aches, muscle weakness, muscle soreness, decreased energy level, occasional night sweats and headaches. Documents held by sender: None.
Information has been received from a licensed practical nurse (L.P.N.) concerning a 13 month old female with no medical history or no drug allergies who on 30-MAY-2008 was vaccinated with a dose of VARIVAX (Merck). Concomitant therapy included PREVNAR and MMR II (MSD). On 24-JUN-2008 the patient developed a rash resembling chickenpox and a low grade fever. The patient came back to the office to seek medical attention. No product quality complaint was involved. Additional information has been requested.
On 9/15/14, pt received PNEUMOVAX 23 in right upper arm and FLUZONE HD in left upper arm. Right arm was sore the next day. On Wednesday 9/17 I was called for advice. The patients right arm was red and warm to the touch from below the injection site to his elbow but not painful. He was advised to contact his physician. After showering, he noticed redness between his legs both front and back. He called his doctor and drove to the office. Approximately 3-4 hours after I saw him, the redness spread to both thighs. At the office the doctor observed him front and back and also noted redness on left lower arm between elbow and wrist. The physician told the patient he was allergic to something in the vaccine. He was also told not to have these vaccines again. (His wife also received both vaccines without incident). The patient was told to take BENADRYL and was given an rx for a MEDROL Dosepak. He took BENADRYL the night of 9/17/14 and began the methylprednisolone Dosepak on the 18th. His rash was mostly resolved by 9/21, with slight redness in the perineum. He was able to on vacation then next week, although feeling a bit tired.
headache; earache; cough; chills; entire body aches/soreness; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; itchy red swollen rash on palms of hands; itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching; right ear swelling/itching; right ear swelling/itching; This is a spontaneous report from a contactable Other HCP (patient). This 32-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 08Jan2021 at single dose (lot number: e13246) for covid-19 immunisation. Medical history included PCOS, HSV2, ADHD, anxiety, depression. Concomitant medications included atenolol (NORTELOL), spironolactone, valaciclovir (VALACYCLOVIR), bupropion. The patient previously received erythromycin and experienced allergies, received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899) at left arm on 14Dec2020 04:00 P.M for covid-19 immunisation. The patient experienced headache, earache, cough, chills, entire body aches/soreness, fatigue, Right arm pit tender/sore, itchy red swollen rash on palms of hands, soles of feet, neck and right ear swelling/itching on 09Jan2021 12:00 A.M. No treatment was received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was recovering.
Arm soreness, blistering at injection site for 3 days post injection, residual scarring. No treatment.
A few hours after the vaccine, I had tenderness and swelling at the injection site. It was a little worse in the morning, and by the end of 1/10/2021, the swollen area was about the size of a silver dollar and itchy. The swelling went down over the next few days until it was a little bigger than a nickel and much less red and tender, so I thought I was fine. But on 1/17/2021 when I woke up, it was red and itchy and swollen up in a larger area than the first day.
diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN ASPART (NOVOLOG), LISINOPRIL, HYDROCHLOORTHIAZIDE, BUPROPION, LEVOTHYROXINE, ROSUVASTATIN, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pfizer Vaccine use for COVID-19 under Emergency Use Authorization (EUA): Pleuropericarditis after receiving Pfizer vaccine 4 days prior to admission. Symptoms include weakness, chest pain, SOB, and DOE. He had a small pericardial and pleural effusion. He was not on any medications prior to admission.
I tested positive for COVID-19 on 10/3/22. I woke with a scratchy throat, fatigue, feverish, and overall body aches and sore joints. I didn't have a cough at that time, but I did get one later. I just felt bad in general. I was traveling so it was terrible. I was traveling when I tested positive and couldn't get Paxlovid, so, I was prescribed Dextromethorphan, Trotipront Max and Paracetamol. I feel much better now, but still have a little bit of a lingering cough.
Information has been received from a RN concerning an 8 yr old female Caucasian student with no prior medical history, who on 13Apr98 was vaccinated with a dose of varicella virus vaccine live at a previous pediatrician's office. No illness was noted at the time of vaccination. On 07Jun05 the pt was seen in the physician's office for a yearly physical when it was noted that she had about 20 vesicular lesions on her trunk and extremities. The pt was diagnosed with classic vesicles of varicella, no other symptoms were observed. No lab or diagnostic tests were performed. The physician recommended isolation until all of the vesicles were broken and crusted. The pt recovered as of 17Jun05. No product quality complaint was involved. Additional information is not expected.
I experienced intense pain (left arm) in the middle of the night after the injection. The intense pain did subside after 2 days. Since that time it is still very painful in the left shoulder area with limited mobility. I also experience shooting nerve pain down the arm into elbow and fingers, up my shoulder into neck and through the middle of my back on left side. I have been taking ibuprofen which really doesn't seem to do anything to relieve pain. I did see my physician at the two week mark and he suggested an EMG and prescribed Vicodin as needed for sleep which I have not needed. I may pursue EMG at a later time also looking into some physical therapy.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 23-SEP-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified): lasting for 48 hours, with the highest recorded temperature of 33 degrees Fahrenheit (0.55 degrees Celsius). The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
606 doses were given after expiration date; Vaccine was stored after expiration date in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator). On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored after expiration date in the refrigerator) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and treatment were reported.  No adverse events reported.   No temperature excursion of the product was reported.  There was no product complaint associated. Vaccine was refrigerated on 27-Nov-2021.   This case was linked to MOD-2022-491837 (Patient Link).
Paresthesias in hands and feet. Raynaud's in hands and feet, muscle fasciculations, diarrhea, nausea, dizziness, pain behind ears and temples. Began after second dose of rabies vaccine. Progressed to involved arms and legs thought to be immune encephalomyelitis or autoimmune demyelination polyneuropathy due to rabies vaccine.
This spontaneous report as received from a nurse refers to a male patient of unknown age. The nurse reported that the patient received his second dose of GARDASIL about 13 months after his first dose. First dose of GARDASIL (lot # reported as 1261AA, exp unspecified) was administered on 04-OCT-2011 and the second dose (lot # H013831, exp unspecified) was administered on 01-NOV-2012. No adverse effects reported. The outcome was unknown at the time of report. Additional information has been requested.
After having the vaccine I have had nose bleeds and severe headaches. I have never had a nose bleed in my life. I have had 12-13 in about a 3 week period. I have only had one in the last week. I can stand on the toilet and it will just pour out of my nose. The first time that it happened there was a big clot but after that I have not seen another clot.  I work for a doctor and I asked him about it after I have had about 6 nose bleeds. He kind of checked me out a little bit and told me to keep a watch on it and see what happens. He did not see anything when he checked me. I continued to have them and he suggested that I go with an EMG.
Approximately 3 days after receiving PROQUAD and KINRIX she developed an itchy maculopapular erythematous (blanching) rash initially on her sides, progressively spread to all of trunk, face and extremities. Very itchy.
Within first 2 days of 2nd dose, had chills, nausea, aches, headache, joint pain,  back pain, fatigue and injection site pain. All but back pain gone by about 3rd day, with injection site pain improving. Back pain continued to worsen, pain in opposite arm begins day 4. Day 5 and 6, back pain Varicose veins  is severe, interfering with movement and work. Opposite arm begins to show tiny bruises at pain site, increasing in size overnight , nausea and headache return.
Woke up 10/4 with lip swelling and tingling of my face. Went to emergency room at hospital. Was started on pred ison , pepcid and benadryl .  On Saturday 10/3 did complain to my husband my arm was swollen and just felt run down
pt woke up crying @ 1AM; mom said pt was burning up & gave pt APAP; 5 mins later pt began jerking & twitching & eyes were in a dead stare; this lasted about 3-5 mins; occured again 1/2 hr later, t 104 ax; taken to ER;
Very sore arm below the injection site radiating down left arm that evening, next time very sick with nausea, faint, and tired enough to go back to bad and cancel plans for the day.  Arm swelled with hot redness and pain on the left side of my body for four plus days.