chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine around 10 am, by 2:00 pm headache, by midnight, chills, bad headache, severe body aches, significant sweating, sleeplessness, fever around 100 degrees, ringing in ears, blood pressure up 4-6 points above normal. Chills and fever gone by 9 am 4/21... body aches, head aches, ear ringing last around 36 hours
This case was reported by a physician to a sales representative and described a 35-year-old subject of unspecified gender who did not respond to immunization with Havrix, for prophylaxis. On an unspecified date in 2005, the subject received 2nd dose of Havrix "according to schedule." On an unspecified date in February 2006, less than one year after vaccination with Havrix, a hepatitis A antibody titer was negative.
Paralysis of both legs; diagnosed with Guillain-Barre Syndrome; treatment: IVIG, physical therapy.
premature ovarian failure; This spontaneous report was received from a physician via a company representative and refers to a 14-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, dose and route of administration were not provided) for prophylaxis. On an unknown date, after finishing regimen of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced premature ovarian failure. The patient sought medical attention. It was unknown if any treatment was given for the event and if any lab diagnostics or studies were performed. The outcome of premature ovarian failure was unknown.  The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1911USA007189:
The next morning his arm was swollen. His mother called the office on 4/11/16. Nurse explained for her to take him to the doctor.
SEVERE CRUSHING HEADACHE, ON AND OFF HEADACHES OF MILD NATURE AND SLEPT MOST OF THE TIME BECAUSE IT WAS DEBILITATING; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 135 pounds, and height was 65 inches. The patient's past medical history included: cigarette smoker, and concurrent conditions included: alcohol user, and non allergy nasal issues, and other pre-existing medical conditions included: The patient had no known allergies, and no history of drug abuse or illicit dug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 07-AUG-2021) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. Concomitant medications included alendronate sodium for non allergy nasal issues, azelastine for non allergy nasal issues, and fluticasone propionate for non allergy nasal issues.  On 20-JUL-2021, the patient experienced severe crushing headache, on and off headaches of mild nature and slept most of the time because it was debilitating. Treatment medications (dates unspecified) included: paracetamol, and acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe crushing headache, on and off headaches of mild nature and slept most of the time because it was debilitating. This report was non-serious.
Per mother, baby vomited X3.  Two times in small amounts, one time with a cup and a half of projectile vomitus.  Per mother, infant isn't having difficulty breathing (no rattling to chest), no rash or fever at this time.
site of inj painful w/swelling (1/2 of arm);given DPH, Oxacillin, Ibuprofen & warm packs; (adm overnoc);d/c on APAP & ibuprofen to f/u w/pvt MD;
Vaccines given at 10am 6/2/04. Hives noted on buttocks at 6PM
After the shot was given I had mild tenderness in the shot area for a few days. It seemed to be getting better but then on the sixth day it began to get worse. My left upper arm muscle near the shot site became very swollen and sore. The muscle feels very hot and tight, like it is contracting. Deep discomfort when I have to use or move my left arm. Overall tiredness, dizzness and slight nausea. I went to see the Doctor again on 2/18/09 but she was not concerned about any of these symptoms. She gave me Lorazapan (I have had panic attacks in the past) and told me to take Motrin and rest.
Blotchy red rash on chest immediately after getting Hepatitis A vaccine. Pt given BENADRYL - rash resolved in 30 minutes.
3 weeks post Tdap vaccination to right deltoid IM c/o continued muscle pain especially at night waking her every two hours and noted daily discomfort and unable to lift arm without discomfort.
Herpes Zoster of face. Painful areas started on face in 3 areas around the mouth that became red and developed blisters within several hours at about 1700 on January 22, 2021
Local reaction characterized by wheal & flare of 6x10cm 2 days p/4th dose in series; also c/o oral lesions but may not be related; no drug allergies; no drug allergies; med includ Corigard, polymicillin for parotid infection;
A few days after I noticed my ears and nose were itching quite a bit. One day I noticed my left nostril was swollen. It felt really weird. Then the skin where my two nostrils and lip meet had split. So I started taking a antibiotic (Clarithromycin 500mg) I had at home and made an appointment with my Doctor. He told me to continue taking the antibiotic and prescribed me a cream (Mupirocin) for the split. The nose swelling has decreased but it is still a little swollen now. It doesn't hurt like it used to.
Injection site pain and tenderness; 16 year old patient administered the vaccine; A spontaneous report was received from a health care provider regarding a 16-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) inappropriately at the age of 16 and experienced injection site pain and tenderness/vaccination site pain.  The patient's medical history was not included. Products known to have been used by the patient were Vitamin D3 and ethinylestradiol, ferrous fumarate, norethisterone.  On 12 Feb 2021, prior to the onset of the events, the patient inappropriately received the first of two doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.    On 13 Feb 2021, the day after the vaccine was given the patient experienced injection site pain and tenderness.  Treatment information was not provided.  Action taken with mRNA-1273 was not reported.  The outcome of the events, vaccine being given inappropriately to a 16-year-old, was considered resolved on 12 Feb 2021.  The event, vaccine site pain and tenderness, was unknown.; Reporter's Comments: This case concerns a 16-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 031M20A), reporting Product administered to patient of inappropriate age with associated adverse event of vaccination site pain. Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Pt. presents to ER on 06/02/2021 stating "has not felt right for a long time". Pt. is not sure how long of time that she has not felt right. Pt. reports this am going to the refrigerator and was not able to grasp a pop. Pt. reports having right hand weakness that started this am. Pt. reports not being able to grasp her phone either due to the right hand weakness. Pt. was found to have an initial temp of 100.4 which spiked to 103.1, HR tachy at 126, BP 108/71, O2 sat on RA 98% and respirations 18. Pt. received and IV lock, fluids, CXR, EKG and CT of ABD and pelvis for c/o abd pain/discomfort and Lab were obtained. Pt. received Rocephin 1 gm IV and Zosyn 3.375 gm IV times 1 dose of each in ED.  Pt. was transferred to Hospital in another area for diagnosis of sepsis and fever of unknown origin for higher level of care.
The person who received the vaccine is the mother of the patient who had the reaction.  Mom received the vaccine and throughout the day continued to breastfeed the child.  About 6 hours later the child developed hives on trunk and extremities.  Throughout the next several days the reaction  has continued.  Mom has been told that she can continue to breastfeed but the child will now be given prn Benadryl.  The child had a fever 3 days prior to the reaction however the rash was not obvious at that time.  If the rash gets worse she has bee told she may need to stop breastfeeding.  Mom will follow up as needed.
Generalized giant hives urticaria 2 days after vaccines, DTap and Prevnar, were given. Treated with Benadryl and Prednisone. Per the HCP follow up report-reporter mentions that patient recovered fine with no problem.
did not feel well; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2020, the patient received the 2nd dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced feeling unwell. In August 2020, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details: Age at vaccination was not reported but patient could be 57 or 58 years of age at the time of vaccination. The patient received the second dose of Shingrix and she did not feel well for 24 hours and then the side effect resolved. The reporter consented to follow up. This case was linked with case US2020156565 by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156565:same reporter
MORNING AFTER RECEIVNG VACCINE C/O SORENESS AND DISCOMFORT GOTTEN PROGRESSIVELY WORSE. ON 12/6/2003 CALLED PHARMASIST AND HE TOLD HER THEY SHOT THE NERVE AND TO TAKE TYLENOL.FEW HOURS LATER CALLED THE ER. AND THEY TOLD HER TO APPLY HEAT COMPRESS. NO RELEIF FROM HEAT COMPRESS.HASN'T SEEN DR. SHE SAID SHE CAN'T AFFORD IT. RECOMMENDED SHE CONTACT DR.
fever, chills, body aches, very weak. Lasted for 3 days. Just starting to feel better now.
P/receiving a dose of Influenza vax, pt exp numbness in arms & legs; MD reported subsequent events indicated the pts sx were clearly due to another illness & were not in any way related to administration of the vax;
Fatigue; fever; chills; extreme dizziness/nausea; extreme dizziness/nausea; headache; malaise; This is a spontaneous report from a contactable other hcp.   A patient of unspecified age and gen-der received third booster dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number: not reported), dose 3 via an unspecified route of administration on an unspecified date as dose 3 (BOOSTER), Single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Historical vaccine received second dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,), via an unspecified route of administration on an unspecified date Single, received first dose bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection,), via an unspecified route of administration on an unspecified date Single for covid-19 immunisation. Fatigue, fever, chills, extreme dizziness/nausea, headache, malaise for 18 hours which started 12 hours third shot (8 months after second shot).The patient experienced fatigue, fever, chills, extreme dizziness/nausea, headache, malaise.  The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
PAIN AT INJECTION SITE RIGHT UPPER ARM FROM TIME OF ADMINISTRATION CONTINUING FOR 1 MONTH  WAITING TO SEE IF ARM PAIN WILL FINALLY STOP
Pt recvd 3 doses of vax p/3rd dose 26MAR92 pt had fatigue, low grade fever, sore throat & myalgia which were a recurrence of previous sxs of JAN92;
ringing ears; nausea; loss of balance; blotting; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ringing ears, blotting, nausea, loss of balance.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029K20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) ringing ears, blotting, nausea, loss of balance.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), ringing ears, blotting, nausea, loss of balance was unknown.
I got my fourth dose of the Pfizer vaccine on 5/7/2022. For at least three weeks afterwards, there was bruising at the injection site. The injection site also bled, and I don't remember bleeding or bruising taking place with my previous shots. On 5/20/2022, I noticed the first shingles lesion in my mouth. On 5/24/2022, I saw my doctor, who agreed that I had shingles and prescribed me an antiviral, valacyclovir. As of the time of this writing, I have no more signs of shingles, so the antiviral worked well. Today is also my last day to take the medication.
Patient presented to emergency department on 8/30/2021 with shortness of breath for last 3 days.  According to paramedics patient symptoms got worse today.  Pulse ox is 88% on 100% on rebreather.  Patient is also tachypneic. Patient is still hospitalized in the ICU as of today.
Pt was given an expired dose of ROTARIX. Vaccine expired 04/10. Dr. advised to redose patient with a non-expired dose of vaccine.
her eyes were swollen; her face that was swollen; This is a spontaneous report from a contactable Consumer (patient). A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Mar2021, the patient experienced eyes were swollen, her husband told her it was her face that was swollen. Patient took 2 Benadryl and the day after as well. The outcome of the events was resolved on unspecified date of 2021.  Information regarding Lot/Batch number requested.  Follow-up attempts are completed. No further information is expected.
tingling in ears and chin after injection. By 11:00 pm, 12 hours after the vaccination, I began developing a painful headache and severe body aches and joint pain from head to toe.  It actually hurt to lay down.  I was unable to sleep, even after taking Tylenol.  I spent the day dozing on the couch and by late evening, about 10:00 pm. I began to feel slightly better.  The pain in my shoulders and the area on my upper back beneath my neck felt like one giant connected  muscle with awful pain that was a combination of pressure and tightness.  I slept well that night and woke yesterday (Sunday) without the severe pain.  No headache and only slight discomfort.  Today (Monday) I feel mostly okay but there is still some residual discomfort even after a 3 mile walk this morning.
Developed case of painful shingles on right side of trunk/back.  Itching and tingling started 2 days after shot, along with weakness and fatigue.  Full-blown shingles a week after the flu shot.  Oral steroid (prenisone) was taken for 10 days with not much success.  Pain and sensitivity continued for 1 month, and symptoms have just subsided in the past couple days.  This link between shingles and flu vaccine really needs to be explored - just look at this website to see stories of people THIS YEAR that have had shingles after flu vaccine: Guillian-Barre syndrome is a rare side effect of flu vaccine.  Guess what a complication of shingles is?  Guillian-Barre syndrome.  They are both inflammations of nerves.  There is a link, and people need to be made aware of this potential side effect.  I hope some studies are being done about shingles and flu vaccine.  This has been a horrible month of my life and I will not get the flu shot ever again.
The patient is 75-year-old male presents the emergency department with generalized weakness and fatigue. Generalized body aches.  Cough and congestion.  Decreased taste and smell started
arm Muscle pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm Muscle pain) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 4782591) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 08-Apr-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (arm Muscle pain) and PYREXIA (Fever). At the time of the report, MYALGIA (arm Muscle pain) and PYREXIA (Fever) had resolved. Not Provided          No concomitant medication information was reported.  It was reported that adult female with events of non-serious arm Muscle pain, and fever with SKYRIZI ( Risankizumab) Solution for Injection, Single-Dose Prefilled Syringe with Needle Guard.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient reported arm muscle pain and fever after receiving covid booster dose.  Agency's opinion was that the causality for the event(s) of arm Muscle pain and fever with Moderna COVID-19 vaccine (Elasomeran) was Not Provided Agency's opinion was that the causality for the event(s) of arm Muscle pain and fever with Risankizumab Solution for Injection was Not Provided.  No treatment medication information was reported.  The MFR CONTROL NO is US-ABBVIE-4177117.
Felt like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt like I had the flu) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INFLUENZA (Felt like I had the flu). At the time of the report, INFLUENZA (Felt like I had the flu) had resolved.            No concomitant medications were provided. No treatment medications were reported.
Noticed tinnitus the day after the first vaccine, which progressively got stronger worse, peaking approximately day 5. After that, tinnitus became less - but never disappeared.  Upon second vaccination, similar timing for increase and decrease. It is now  30 days since the second vaccine shot and tinnitus is still present.
Shortly p/pt recvd 1st dose of engerix-B, pt exp severe quincke's edema; Pt was hospitalized & recovered; MD indicated that this allergic rxn could be related to HG in the thiomersal preservative;
I had a major reaction and broke out with shingles; very painful; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2021, the patient received Shingles vaccine. In August 2021, 5 hours after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as the case was reported by patient. The age at vaccination was not reported. The patient had shingles shot at 5 one day and by 10, the patient had a major reaction and broke out with shingles Till the time of reporting, it had been 3 weeks and the patient stated he/she was on 4 different mess to help and it was still very painful. The follow-up would not possible as no contact details were available.
Hib: 22-MAR-2004, 04-JUN-2004, 12-AUG-2004, 11-APR-2005, 18-OCT-2005; Hib: 22-MAR-2004, 04-JUN-2004, 12-AUG-2004, 11-APR-2005, 18-OCT-2005; Hib: 22-MAR-2004, 04-JUN-2004, 12-AUG-2004, 11-APR-2005, 18-OCT-2005; This spontaneous report has been received from a licensed practical nurse, via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL)(2303USA000170), concerning a 6-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies prior to vaccinations were not reported.  On 22-MAR-2004, the patient was vaccinated with the first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. On 04-JUN-2004, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis. On 12-AUG-2004, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). On 11-APR-2005, the patient was vaccinated with the fourth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (extra dose administered). On 18-OCT-2005, the patient was vaccinated with the fifth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection (exact dose, strength, lot #, expiration date, site and route of administration were not provided) for prophylaxis (extra dose administered).  This is one of several reports regarding the same patient.  All available medical records will be provided upon request.; Sender's Comments:  US-009507513-2303USA000170:Original case 2303USA000170 US-009507513-2306USA000601:Split report 2306USA000601 US-009507513-2306USA000599:Spit report 2306USA000599
patient developed diarrhea after receiving two shots in office, diarrhea persisted x3 weeks causing low potassium resulting in shock for defibrillator.
I got the shot around 2 in the afternoon.  By supper time, I was feeling really nauseous and having pain in my stomach.  By bedtime I was doubled over in pain.  That lasted for several hours before my husband took me to the ER.  They found that my appendix was going to rupture and took me to emergency surgery.  I never had a problem with my appendix before then and have never had another major surgery (only other surgery was ear tubes as a child).