chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist, refers to a patient of unknown age and gender. Information on patient's medical history and concurrent conditions was not provided. On 10-JAN-2018, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 PFU, either from lot # N016185, expiration date 31-JUL-2018 or from lot # N021170, expiration date 27-OCT-2018 (dose number and route of administration were not reported) for prophylaxis.  Other suspect therapies included STERILE DILUENT. The pharmacist reported that, on an unknown date, the dose of ZOSTAVAX that was administered to the patient, suffered a data logged temperature excursion from 15°F to 46°F for 4 hours and 45 minutes. He also reported that a previous data logged excursion occurred, on an unknown date, from 15°F to 46°F for 7 hours and 45 minutes. No adverse effects were reported.
Itchy rash all over body. No other side effects. No trouble breathing. Came on Sunday morning first just on my left arm and now is on my chest, both arms, and legs. Would not consider it severe but it definitely is an adverse reaction.
Patient was given a  dose of a Pfizer vaccine out of vial that was opened on 7/19/22 at 11am making the vial expiring at 11pm. The 0.3 mL dose was administered on 7/20/22 at 10am.
11/1/01 pt reported having a light red rash all over her body. Dry rash.
Acute onset of urticarial rash and eye swelling about 30-45 minutes, post vax. Pt was seen by another physician and given Epinephrine, SC.
Information has been received from a registered pharmacist concerning a 52 year old male patient with no known drug allergies who on 02-JUN-2010 was vaccinated with a dose of MMR II. On 09-JUN-2010, the patient experienced arthralgia in his wrist and other areas such as knees and elbows after administration of MMR II. He had pain and swelling in his joints. The patient's adverse events persisted. The patient sought unspecified medical attention. Follow up information has been received from the physician who reported that they did not see the patient for the adverse events reported. Additional information has been requested.
After taking the vaccine around 9:45 am, 1/27, I started feeling mild pain so took ibuprofen.  -after an hour or less, I started getting itchy, burning hives all over my face and scalp.  - hives disappeared by the end of the day. - next morning there was bad headache, almost passed out, threw up. -entire body pain for atleast 3 days - have been getting hives on face on and off till this date 2/2.
Was given a Tdap and every since I have not been able to use my arm properly and have been in pain (paper included).
Fever (102), chills, myalgia, hyperesthesia gradually resolve over 2 days
respiratory virus; This is a spontaneous report from a contactable consumer. This consumer reported for his wife (patient) in response to non-health care professional letter. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch / Lot Number: not reported), via an unspecified route of administration on 08Feb2021 (age at vaccination was 51 years) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 on 18Jan2021 (age at vaccination was 51 years) for Covid-19 immunization. Beginning on 17May2021, the patient contracted a respiratory virus. On an unspecified date the patient tested negative for Covid-19 (PCR and rapid) during their periods of infection and not tested for Covid 19. Outcome of the event was unknown.  The lot number for the vaccine was not provided and will be requested during follow up.
Fever up tp 102° sweats and body aches headache and loss of appetite lasted 11 days after vaccination
7/8/99 Blood work, aching. 11/16/99 Blood work, aching. Increased arthritic pain in feet, hands, jaw--same. Diagnosed with fibromyalgia 5/27/98. Paxil, Ultram and Klonopin. A follow up report received 7/29/2003 adds: Symptoms became worse after dose #3 received on 4/17/2000. Note: Dose #1 received 5/28/1999-more than 4 weeks prior to dose #2 on 7/8/1999. The medical records received on 10/22/03 states anxiety, fatigue, and memory problems. The medical record received on 12/4/03 states anxiety, fatigue, and memory problems.
Client presented for flu shot.  PHN mistakenly administered a 0.3 dose of Pfizer COVID-19. PHN observed error immediately and reviewed with colleague. Client had completed 2 COVID doses over 5 months prior. PHN checked on health of client. PHN administered dose of flu vaccine. PHN discussed possible adverse outcomes, reviewed how and when to seek medical care, then had client remain in clinic for 15 minute observation. Client left the clinic "feeling fine".
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported two cases for same drug and different events/patient (brother and sister). This is one of the two reports. A 13-year-old healthy female patient of an unspecified ethnicity received. on 25Aug2015 at 09:30, TRUMENBA (Lot. L13515), intramuscular in the left arm, at 0.5 ml, single dose, for immunization (prevention of type b meningococcal infection). The vaccine was administered at the private doctor's office/hospital and was purchased with private funds. Relevant medical history and concomitant medications were unknown. The patient experienced nausea, swollen arm and lower back pain on an unspecified date. The events did not require an emergency room or physician visit. No hospitalization was required. The patient recovered from the event, nausea on 30Aug2015; while clinical outcome of the other events was unknown. The case was assessed as non-serious. There was a reasonable possibility that the events were related to meningococcal group b rlp2086. Follow-up (09Oct2015): New information reported from the same contactable physician includes: patient details, suspect drug details, and reaction data. Follow-up attempts obtained. No further information expected.
big red blotch just below the injection site; Macule; experienced arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2021, the patient received the 1st dose of Shingrix. On 9th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 11th July 2021, the patient experienced red blotches and macule. On an unknown date, the outcome of the pain in arm, red blotches and macule were unknown.   It was unknown if the reporter considered the pain in arm, red blotches and macule to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. The patient reported that, after receiving 1st dose of Shingrix vaccine he experienced arm pain.  Upon examination at 21:00 on 11th July 2021, the patient noted a big red blotch just below the injection site from which he was experiencing the pain and experienced macule. No further information was reported. The reporter consented to follow up.
extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back; lost appetite/barely eats; lost 20 pounds; Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock; hurts so bad sometimes/pain; drives him crazy; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back), DECREASED APPETITE (lost appetite/barely eats), WEIGHT DECREASED (lost 20 pounds), MUSCULOSKELETAL STIFFNESS (Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock) and PAIN (hurts so bad sometimes/pain) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was provided.  Concomitant products included DULOXETINE for Antidepressant therapy, GABAPENTIN for Sleep disorder.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back), DECREASED APPETITE (lost appetite/barely eats), WEIGHT DECREASED (lost 20 pounds), MUSCULOSKELETAL STIFFNESS (Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock), PAIN (hurts so bad sometimes/pain) and FEELING ABNORMAL (drives him crazy). At the time of the report, MUSCLE SPASMS (extreme muscle spams everyday/started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back), DECREASED APPETITE (lost appetite/barely eats), WEIGHT DECREASED (lost 20 pounds), MUSCULOSKELETAL STIFFNESS (Wakes up stiff as a rock/Every morning every day I wake up stiff as a lock), PAIN (hurts so bad sometimes/pain) and FEELING ABNORMAL (drives him crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. Concomitant medications include antidepressants.   This case was linked to MOD-2021-255826 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13 Jul 2021- Route and administration site was updated. Concomitant drug Duloxetine was updated and indication for both the concomitant medications were updated.Verbatim term updated.
I had issues with menstrual cycle. I had the booster in Jan. 2022. I have not received a menstrual cycle yet. Passed large blood clots about a week ago.
Cellulitis. Fever. OMNICEF 250/5. EMLA cream. MOTRIN suspension.
The day after getting the 2nd shot I developed a sore arm and headache..the sore arm went away but the headache persisted every single day, 5 days after the shot I started having double vision and still have it and I feel unwell. I have nausea , dizziness, headache and just general feeling of being unwell..a bit of tightness in my chest
body muscle aches, chills, bloody nose, fatigue, fever 100.2 f, headache, ears tingling which started on 1/13/21 at 4 pm. Pt. states that he still has symptoms despite taking tylenol. nose stopped bleeding after ten  minutes.
Pt experienced edema (med) with erythema and painful to touch. Inflammation, parent denies fever. Cellulitis diagnosed by ER physician.
Patient was extremely tired the day after getting the shots. She kept expecting to get better but by the following Saturday, we took her to the Emergency room. She was very low on magnesium, potassium, and platelets. They admitted her to the hospital, and she had one good morning but most of the time she thought she was going to die. (She is not like that normally) I believe it was Saturday 10/29 that she woke up having a horrible time breathing. They gave her breathing treatments but nothing helped. They took an X-ray and her lungs were very full of fluids. They said that they could drain her lungs, but the fluid would probably come back. The other option was to put her on Comfort Care, which we did. Sunday afternoon around 2:30 she passed away.
BABY NOT ABLE TO SWALLOW FULL DOSE DUE TO SPITTING OUT; Not able to swallow full dose; Tasted very bad, appeared oily; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 17-APR-2023, the patient received Rotarix lyophilized formulation. On 17-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced accidental underdose (Verbatim: Not able to swallow full dose) and product complaint (Verbatim: Tasted very bad, appeared oily). On an unknown date, the patient experienced regurgitation of medication (Verbatim: BABY NOT ABLE TO SWALLOW FULL DOSE DUE TO SPITTING OUT). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth, which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter
Next day painful, red, sl raised, painful to move arm, warm, hard. 5/27/03 improved. Bat still warm red and sl raised.
Redness, warmth, swelling from shoulder to her elbow TX'd with Keflex per mom. 05/17/06-16 page hospital record reviewed from hospital, includes ED, H&P and DC summary. Hospitalization 4/13-4/14/06(15 hour stay)-admitted with diagnosis cellulitis and reaction to immunization. RX at hospital with Kefzol. DC diagnosis Adverse reaction to immunization and possible infection of arm. DC medications include Melatonin, Keflex and Ibuprofen.
lingering cough; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of COUGH (lingering cough) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (lingering cough). At the time of the report, COUGH (lingering cough) outcome was unknown. Not Provided    Action taken with mRNA-1273 in response to the events was not applicable   Concomitant medications were not provided. Treatment information was not provided.
Next AM woke up arm super painful. Lymph node armpits was the size of a lemon. Swollen for 3 days before the swelling began to go down. Still a little swollen pain is 2 out of 10.
Fever; headache; chills; sweating; sick all day; slightly sore are; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (slightly sore are), PYREXIA (Fever), HEADACHE (headache), CHILLS (chills) and HYPERHIDROSIS (sweating) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (slightly sore are). On 11-Jan-2021, the patient experienced PYREXIA (Fever), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and ILLNESS (sick all day). At the time of the report, PAIN IN EXTREMITY (slightly sore are), PYREXIA (Fever), HEADACHE (headache), CHILLS (chills), HYPERHIDROSIS (sweating) and ILLNESS (sick all day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter.  No treatment was reported.; 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.
Atopic dermatitis (eczema) flare up after 2 to 3 week post 1 shot. Currently on week 4, and it's getting worse, eczema in area which I rare or almost never had issue before. patch spread to size of my hand, starting to find red dots all on limbs. Second shot not yet taken, will be getting it in a few day.
1 hour after injection, pt c/o palpitations and a brief episode of her lips suddenly felt cold and then quickly returning to normal. She has also has experienced palpitations intermittently in the weeks following vaccination.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 10-NOV-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 (dose and route of administration was not reported) lot # M047519, expiration date: 04-AUG-2018 for prophylaxis. The vaccines was stored in between 47 and 77 (67) Fahrenheit degrees for 12 hours. There was no previous temperature excursions. The Digital Data Logger was involved. No adverse effects were reported.
Low grade fever of 99.9F, body aches, chills and diarrhea.
Information has been received from a licensed practical nurse concerning a 20 year old female who on 10-JAN-2008 was vaccinated with Gardasil (Lot # 659653/1448U). Concomitant therapy included MICROGESTIN FE and on the same day received diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 10-JAN-2008, 10-15 minutes after receiving the vaccines, the patient fainted. She immediately had an innocuous seizure, and sustained a bump, an "egg," on her head and laceration on forehead. Dermabond was applied to the laceration. The nurse attempted to sit the patient up and the patient had another seizure. The seizures lasted 10-15 seconds. She was placed on an exam table for an hour and was better. The patient's blood pressure was fine and the patient was sent home. Subsequently, the patient recovered. Upon review, the seizures were upgraded to serious due to an other important medical event. Additional information has been requested.
Initial unsolicited report received from a nurse on 10 June 2015. A 20-year-old male patient, concomitant medications were not reported, had received a dose of ADACEL (batch number - C4713AA, route of administration, site of administration were not reported) and second dose of VAQTA (batch number- K024697, Manufacturer-Merck, route of administration, site of administration were not reported) on 26 May 2015. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as allergic to penicillin. On 26 May 2015; within 24 hours after vaccination, the patient experienced fever, arm soreness and body aches. Then within 1 week after vaccination the patient also experienced intermittent "tetany-like" or muscle spasms of arm. Laboratory investigations corrective treatments were not reported. At the time of this report, the patient was not recovered from intermittent muscle spasms and intermittent "tetany-like" or muscle spasms of arm and outcome of other events was unknown. Documents held by sender: none. Follow-up information received from a nurse on 27 July 2015. A male patient had received first dose of VAQTA (expiry date: 28 April 2017) and a dose of ADACEL (expiry date: 01-April 2017) both vaccines via intramuscular route in left deltoid on 26 May 2015 and a dose of TYPHIM VI (batch number K1200, expiry date: 15 April 2016) via intramuscular route in left deltoid on 18 May 2015. The patient had also received a booster dose of VAQTA on "12 January 2015". On an unknown date, one week after vaccination (tdap and hepatitis A vaccine), the patient had developed muscle spasm in left arm. The patient was prescribed with ciprofloxacin 500 mg (quantity: 20), MALARONE 250/100 mg (quantity: 44), ibuprofen as needed (for arm soreness). At the time of the report, the patient was recovered from the event intermittent muscle spasms / intermittent "tetany-like" or muscle spasms of arm, fever and not recovered from arm soreness. Documents held by sender: none.
Injected in left arm, and where they vaccinated have a red spot.; Injected in left arm, and where they vaccinated have a red spot and its swollen.; Injected in left arm, and where they vaccinated have a red spot and its swollen and causing pain.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Apr2021 at 17:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin. The patient had known allergies to codeine and carbamazepine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included baclofen (BACLOFENE), trazodone (MANUFACTURER UNKNOWN) and venlafaxine hydrochloride (EFFEXOR); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 17:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 08:00, the patient experienced red spot and swelling where she got injected and it caused pain. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, patient had not been tested for COVID-19. The clinical outcome of the events red spot and swelling where she got injected and it caused pain was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe myalgia developed 6 days after the initial vaccination  (January 12th) following my arthritis-like symptoms. Unable to move and required OTC pain medication to function. Duration of symptoms lasted on week.  Second Vaccination occurred February 10th.  Similar pattern of myalgia and arthritis-like symptoms (including swollen fingers) developed 2 months later and lasted 48 hours. Unable to move  and function.
A pharmacist reported that in 1996, he received an injection of flu vax and subsequently developed an injection site reaction. The pt recovered.
Baby crying temp 103.6R had apnea x 2, mom stimulated baby for breathing; Stated baby had wheezing w/dyspnea w/tachypnea;