chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Provider's note: She notes that she has been seeing some spotting from her IUD since her COVID vaccine. She notes that she may get some spotting, then her menses, then again some spotting. Prior to the vaccine, she would get her menses once per month and did not have any spotting.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 04-DEC-2012 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 26-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 13-SEP-2016the patient received subsequent treatment for new and ongoing symptoms, at which time an examination revealed a herpetic infection of his eye, also known as keratoconjunctivitis, an ocular condition secondary to shingles. The patient has been prescribed antihistamine drops and an eye patch for management of his persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review herpetic infection of his eye was considered a medically significant event. Additional information has been requested.
The day after the vaccine was received (2-21-18), patient presents to the pharmacy around 8 PM with an injection site reaction. Pt's experienced erythema, swelling, warmth, with a defined border of 3 inches by 4 inches. Pt also was experiencing soreness. Pt did not say that there were any adverse effects the same day as the vaccine (2-20) except soreness. This had gradually worsened throughout the day (2-21). I told the patient to put some hydrocortisone cream to help with the swelling, take a BENADRYL, and then ice the areas (since the heat was really concerning her). Will follow up with patient 2-22.
ACT-HIB reconstituted with sterile water instead of 0.4% NaCl saline diluent with no reported adverse event; Initial information was received on 30-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional via the [Reference Information (MI) - 00793063].  This case involves a 13 month-old male patient who was vaccinated with HIB (PRP/T) VACCINE [ACT-HIB] which reconstituted with sterile water instead of 0.4% NaCl saline diluent (Product preparation error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and HEPATITIS A VACCINE  for prophylactic vaccination.  On 29-Sep-2021, the patient received first dose 0.5 mL suspect HIB (PRP/T) VACCINE  (strength: standard; lot UJ383ABA and expiry date 11-Oct-2021) via an intramuscular route in the right vastus lateralis for prophylactic vaccination.  It was reported "Caller reports that a patient was administered ACT-HIB; states ACT-HIB was reconstituted with sterile water instead of the provided 0.4% NaCl saline diluent. Caller asks if this dose would be considered valid. Caller also asks, since ACT-HIB would not be considered valid, if patient should be revaccinated right away or if there is a waiting period. Caller states that patient did not receive treatment for adverse events related to ACTHIB".  It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
rash began before 2nd shot, peaked after, treatment began 7 weeks later, dormant fungus reappeared, mild recurrence after 3rd shot rash aggravated by going outside (oak allergy? never before encountered).  treated OTC with cortisone-10. Under medical supervision triamcinolone, dermatology soap, vanicreme, ketoconazole.  From 2 weeks after 3rd shot, all symptoms cease after med applications
I received the first vaccine on 09/09/21 and had some itching on scalp, but the second vaccine on 10/07/21 a few days after I have had uncontrollable itching which created whelks, rash, bumps and very warm to the touch. I went to Clinic to see what was causing this and then realized the time frame it was the vaccine that had created this issue. They prescribed me steroid cream and pills, the cream has not helped. I am now almost 2 weeks out from the 2nd dose and am still having terrible itching and raised bumpy areas to the skin and back of scalp. This has effected my arms, hands, legs and back of scalp.
The pt developed red, swollen, and painful right deltoid on 12pm on 05/23/2002 with no fever.
Light headed; Feels itchy around shot site; Left arm red around injection shot; Left arm is hot and warm; Soreness of left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of left arm), FEELING HOT (Left arm is hot and warm), DIZZINESS (Light headed), VACCINATION SITE PRURITUS (Feels itchy around shot site) and VACCINATION SITE ERYTHEMA (Left arm red around injection shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Depression. Concomitant products included ESTRADIOL for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (Soreness of left arm). On 06-Apr-2021, the patient experienced FEELING HOT (Left arm is hot and warm), VACCINATION SITE PRURITUS (Feels itchy around shot site) and VACCINATION SITE ERYTHEMA (Left arm red around injection shot). On 07-Apr-2021, the patient experienced DIZZINESS (Light headed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Soreness of left arm), FEELING HOT (Left arm is hot and warm), DIZZINESS (Light headed), VACCINATION SITE PRURITUS (Feels itchy around shot site) and VACCINATION SITE ERYTHEMA (Left arm red around injection shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication includes Tylenol
Influenza 3 years & above with Preservative is the vaccine. Chills, fever the night of the vaccine, then developed 1st ever ear infection then progressed to Guillain Barre Syndrome and advanced to CIDP.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 17-month-old female patient who received FLULAVAL (batch number 5AZ7H, expiry date 30th April 2015). On 29th September 2014, the patient received the 1st dose of FLULAVAL. on an unknown date, an unknown time after receiving FLULAVAL, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to FLULAVAL. Additional information received: Patient of 17 months of age who received inadvertently FLULAVAL QUADRIVALENT. Child too young for indicated age for vaccine.
Low grade fever of 100.2, shakes, Body Ache, Mild headache, and nauseous from about 8 on Tuesday and felt better by Thursday morning
A report was received from a health care professional on 09/23/2002, concerning a female patient in her 20's who experienced injection site soreness after receiving Fluvirin on 09/19/2002. On 09/19/2002 the patient received Fluvirin and experienced injection site soreness shortly after. The soreness worsened over the next couple of days, spreading throughout the entire arm. On 09/23/2003 the patient still experienced arm soreness. At the time of the report the patient had not recovered. The reporter has assessed the relationship of study medication to the event as possible and the health professional is concerned that the event may have been associated with this particular batch.
Severe pain at injection site, stiffness, sharp pain, cannot lift my arm.  It has been two days and still have very bad pain in that arm.
tummy was weird; fainted; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: En6203), dose 2 via an unspecified route of administration, administered in arm right on 07Jun2021 15:30 (at the age of 27-year-old) as single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm, on 17May2021 15:45 (lot number: En203) for COVID-19 immunization. On 08Jun2021 05:15, patent experienced fainted morning after vaccine, and was lightheaded, tummy was weird too. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.
Patient received the 2013-2014 flu vaccine in August 2013 and another one was received 6/6/14.
OBSTRUCTIVE SLEEP APNEA 5/3/2023 LOC-REL IDIO EPI W/SEIZ LOC ONSET INTRCT W/O SE
Pt. feels like blackingout, seizures ~ 1 min. Pt was placed on flat position. EMS was called. Pt. wa staken to ED.
Erythema, Edema, warmth to touch. 10/20/06 10x7 in size. Treatment with Levaquin 500mg 1tab x 10 day, Claritin 10 mg daily.
Patient experienced sensitivity to light, nausea, headaches, and lethargy starting 6/18/20. She reported 6/30/20 that the symptoms of headaches and lethargy have not gone away still. She will experience a good day followed by another day of severe headaches and lethargy.  Patient is planning to visit physician regarding side effects.
Injection arm was red from shoulder to elbow. Redness remain for 5 days. Itching started 1 day after redness and lasted for 4 days
Rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (Covid 19 Vaccine) lot no: EK9231, via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got the vaccine on 30th December, the first dose and the patient got a rash. Outcome of the event was unknown.
Had a grandmal sz last for 50 min was transported to Hosp in ICU for 3 days; had a Cat Scan, sp tap & blood work all normal; no fever; was put on Dilantin @ that time; Was referred to a neurologist which are still seeing; is now on Depakote
Diarrhea that lasted for 5 days, about 3-4 days after each dose, moderate to severe fatigue that lasted for 4 days, and injection site soreness
This spontaneous report as received from a consumer refers to an 84 year old female patient who was reporting on herself. No concurrent conditions, historical conditions or concomitant medications were reported. The patient had no previous drug reactions or allergies. On an unspecified date in 2009, the patient was vaccinated with ZOSTAVAX (dose, lot # and expiration date were not provided, route of administration was reported as injection ). On an unspecified day in approximately May 2016 (reported as "two months ago"), the patient experienced a case of shingles. An unspecified treatment was given for this adverse event. No laboratory diagnostic studies were performed. The patient did not seek medical attention. The outcome of the event was reported as not recovered/not resolved. The causality was not provided. Additional information is not expected as the reporting consumer did not wish to be contacted.
Induration 4 cm with 9 cm erythema painful. Began 24 hours after vaccine administration ice MOTRIN BENADRYL. Improved by 4/24/16 with treatment.
Dose was given at age 11 in error/ not give the second dose at age 11; This case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a 11-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose on an unknown date when he was 11 years old).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was given the 1st dose of Bexsero vaccine at the age of 11 by error. The health care provider had planned to give two doses when the patient would turn 16.  The patient did not receive the 2nd dose of Bexsero vaccine till the time of reporting, which led to incomplete course of vaccination. The patient received the 1st dose within the age range of the label; however, it was clear the vaccine was given to the patient in error by the provider's Medical Assistant. The physician did not consent to follow up.
A patient was given Day 1,3,and 7 but not day 14 of rabies vaccine; Initial information received on 07-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown age patient who missed the day 14 dose of RABIES (HDC) VACCINE [IMOVAX RABIES].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error due to missed dose.   It was reported that patient was given Rabies vaccine Day 1,3,and 7 but not day 14. It was reported that patient asked if this was sufficient or if the full rounds need to be repeated.   It was not reported if the patient experienced any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
First client complained of a dry throat.  Water given to drink.  Client continued to complain of itchy palate, felt like throat was swelling, and throat burning.  Benadryl 50mg IM given.  Itchy palate resolved, but client continued to complain of throat burning.  Client with no distress, no trouble breathing.  Client refused EMS transport, but did agree to go to ER with husband.
I received the COVID-19 Moderna shot on 1/15/21 and again on 2/12/21.  After receiving the shot I started to experience arm pain in my shoulder area where the shot was given.  I kept expecting this arm pain to subside and go away, as all the media reports have been that the arm pain is not something to worry about and that it will go away in time.  However, the arm pain has not subsided or gone away, in fact, it seems to be getting worse for me over time.  It is hard for me to lift my arm above my head, and I generally feel pain and discomfort in my left arm.  My left arm is certainly still useable to a large degree, so it isn't like it completely disabled my arm but I can still feel a discomforting feeling or sensation that something in my arm is damaged.  I think the vaccine shot did something bad to my arm because I did not have this pain/sensation prior to the shot.  When I go to put something in the microwave or generally lift my arm upwards like to put something on a shelf or anywhere eye level or above I experience the pain which is a bit of a burning sensation.  I can still lift things and pick up things but my left arm feels weak.  I really think the vaccine screwed up my arm in some manner and I'm concerned it may be permanent because it isn't going away.  I am going to go talk to my primary care physician about the issue and see if I get can some physical therapy or something and have scheduled a future appointment.  But I thought the government should want to know about this in case I am not the only one experiencing such arm pain after vaccination.
Pt was shaking both upper & lower extremities w/stiffness & acrocyanosis; Episode lasted approx 5 mins; Pt brought to ER & noted to have t104; Dx febrile seizure secondary to immun rxn;
This medically confirmed report (initial receipt 25-Jun-2012) concerns a female patient. In 2009, the patient received influenza vaccine (manufacturer and batch number not specified). The patient suffered a severe reaction. She experienced an arthritic episode. She sought medical attention, had a spinal tap and received medical treatment. The episode lasted 2 months. Reporter's comment: Upon follow up with the physician's office on 10-Jul-2012, the CMA (clinic medical assistant) mentioned that there was no record of the patient receiving any influenza vaccine. The CMA stated that the patient had called the physician's office in Jun-2012 to inquire about when she received the influenza vaccine. The CMA stated that the patient was told at that time that there was no record of the patient receiving an influenza vaccine. Follow up (10-Jul-2012): reporter's comment.
This medically confirmed spontaneous report (initial receipt: 26-Feb-2016) concerns a 36 year-old female patient. On 21-Sep-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5 ml via the intramuscular route. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug or allergy reactions were not provided. On 30-MAY-2018, the patient was inadvertently administered with PROQUAD (lot number N024562, expiration date 06-MAR-2019) and VARIVAX (lot number N027000, expiration date 28-SEP-2019), by subcutaneous route (strengths, doses and dose numbers were not reported), for prophylaxis.
6 hours of Diarrhea, vomiting, flushing, headache, shaking.   No fever
Saturday evening started feeling achy,  Sunday same- felt worse- Monday early BP shot up to 220. She had a stroke.
Had reactions; Sick to her stomach; Felt like she was going to get a sore throat; It felt like something was stuck in her throat; She could barely walk back & forth to the bathroom; Had dizzy spells to the point where she could barely walk back & forth to the bathroom; Was nauseated; Head hurt; Left arm hurt really bad & it felt beat to a pulp; Had excessive air coming up & was burping; Was in bed for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had reactions), BEDRIDDEN (Was in bed for 4 days), ABDOMINAL DISCOMFORT (Sick to her stomach), ERUCTATION (Had excessive air coming up & was burping) and OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Environmental allergy and Allergy to antibiotic (Allergic to antibiotics).    On 29-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had reactions), BEDRIDDEN (Was in bed for 4 days), ABDOMINAL DISCOMFORT (Sick to her stomach), ERUCTATION (Had excessive air coming up & was burping), OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat), OROPHARYNGEAL DISCOMFORT (It felt like something was stuck in her throat), GAIT DISTURBANCE (She could barely walk back & forth to the bathroom), DIZZINESS (Had dizzy spells to the point where she could barely walk back & forth to the bathroom), VACCINATION SITE PAIN (Left arm hurt really bad & it felt beat to a pulp), NAUSEA (Was nauseated) and HEADACHE (Head hurt). At the time of the report, VACCINATION COMPLICATION (Had reactions), ABDOMINAL DISCOMFORT (Sick to her stomach), OROPHARYNGEAL PAIN (Felt like she was going to get a sore throat), OROPHARYNGEAL DISCOMFORT (It felt like something was stuck in her throat), GAIT DISTURBANCE (She could barely walk back & forth to the bathroom), DIZZINESS (Had dizzy spells to the point where she could barely walk back & forth to the bathroom), NAUSEA (Was nauseated) and HEADACHE (Head hurt) outcome was unknown and BEDRIDDEN (Was in bed for 4 days), ERUCTATION (Had excessive air coming up & was burping) and VACCINATION SITE PAIN (Left arm hurt really bad & it felt beat to a pulp) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Before getting the dose the patient had tested positive for Covid..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2022-474388 (Patient Link).