chrisvoncsefalvay/vaers-outcomes huggingface dataset:
white blood count is quite high; This case was reported by a consumer via call center representative and described the occurrence of white blood cell increased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received Shingles vaccine. In August 2022, 2 days after receiving Shingles vaccine, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was not recovered/not resolved.   It was unknown if the reporter considered the white blood cell increased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 12-Aug-2022 Reporter's Comment: The reporter reported this case. The patient received dose of Shingles vaccine and two days later he/she had bloodwork done and he/she just got the lab results and his/her white blood count was quite high.  The patient asked was there a correlation between the shot and increase in his/her white blood cells. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Upon admission, the patient states he had his first Covid shot 2 days ago.  He had some body aches and arm pain following the injection.  He states last night around 5 or 6 PM he had sudden onset of diffuse upper abdominal pain.  He states when it began it did radiate to his right chest and his neck.  There was no associated nausea, vomiting, diarrhea, or black or bloody stools.  No fever, chills, or sweats.  No cough, nasal congestion, or sore throat.  No shortness of breath or palpitations.   Patient was seen by surgical services and his scan was suggestive of acute cholecystitis.  Patient underwent robotic laparoscopic cholecystectomy by general surgery.  He did not develop any complications.  Patient was able to tolerate regular diet without any significant worsening of his pain so he was discharged home on same day after his cholecystectomy.  He also noted to have AKI which was improving.  He was advised to follow-up with his primary care physician and have a repeat BMP done in 1 week.  He will also need follow-up with surgical services in 2 weeks.
I was positive for COVID-19 on 17APR2023, I had a throbbing headache it felt like allergies. I had night sweats, fatigue and fever. All the sudden I felt good then it hit me again, its been up and down the past 8 days. I did not seek medical treatment.
Diffuse non pruritic maculopapular rash on trunk day after administration. Advised supportive care.
lethargic for about 2 or 3 days; arm still hurts from it; it put you to sleep almost for 3 days; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2 NOS), as dose number unknown (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: LETHARGY (non-serious), outcome "unknown", described as "lethargic for about 2 or 3 days"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "arm still hurts from it"; HYPERSOMNIA (non-serious), outcome "unknown", described as "it put you to sleep almost for 3 days".  Additional information: The patient was 65 years old. The patient stated, "It was of Pfizer vaccine, the first booster (Pfizer COVID-19 Vaccine) caused the patient to get lethargic for about 2 or 3 days and the patient's arms still hurts from it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness at various times of day. Exacerbated when changing position (lying down, sitting, standing). Comes and goes throughout the day. Varies in intensity from 2 out of 10 to 5 out of 10. Does not seem to go away even after doing Epley maneuver.   I have previously had bouts of Vertigo that come out of the blue. Been tested at an ENT's office, inconclusive.
Right side of right leg was numb, it is no longer numb; Toes began to tingle, feeling in my toes is back; This is a spontaneous report from a contactable consumer (patient himself). A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number e206; Expiration Date: 17Mar2021) via an unspecified route of administration on 09Mar2021 (at age of 71-year-old) as single dose for COVID-19 immunization. Medical history included fungal skin infection, hypoaesthesia and head injury from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced right side of right leg was numb, it is no longer numb and toes began to tingle, feeling in my toes is back. It was reported that, patient had a very exciting and wonderful news. On 09Mar2021, he had received first injection, on 24Mar2021, he had a very radical changes in body. He had a toe fungus that he have been living with for 15 years. His toes were numb for the last 10 years, could not feel them. Last on the 24th in the middle of the night his toes began to tingle and woke him up. The feeling in his toes was back. Many years ago when he was in his 30's he had a head injury so my right side of right leg was numb, it was no longer numb. Patient's diet has not changed, nothing has changed except the COVID vaccine. All he knew it that since the injection the absolute numbness of my toes was almost gone, he can feel the movement of toes and on the right side of my right leg the numbness was gone. For him it was a whole lot. Till now patient did not received second shot of vaccine. The patient did not receive any treatment for adverse event. Outcome of both the events was recovered on 24Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 31-OCT-2015 16:00, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.4 and 2.4 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Alopecia; Flu like symptoms; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Alopecia), INFLUENZA LIKE ILLNESS (Flu like symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On 24-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced ALOPECIA (Alopecia) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, ALOPECIA (Alopecia) had not resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Concomitant medication was not reported.  On an unknown date, it was reported Humira was not as effective. Treatment details not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt developed an approx 10x20cm area of redness and induration at the left deltoid where the immunization DTaP was given. No anaphylaxis. No fever.
Subsequent to receiving two doses of varicella virus vaccine live the pt experienced a temperature of 100F with nausea and headache.  Two days later the pt experienced a pruritic rash resembling chickenpox on her neck which spread to her chest. The pts rash was not weeping but appeared raw and spread daily through her entire body except below the knees. Physician felt the rash appeared to be chickenpox. Pt was treated with Benadryl and Caladryl. Approximately 5 days later pt still had a slight fever and some itching and her rash appeared to resemble pityriasis rosea.
Information has been received from a nurse practitioner concerning an 82 year old female with hypercholesterolaemia, hypothyroidism, hypertension and allergy to codeine who on 08-DEC-2006 was vaccinated SC with a dose of Zostavax (lot # 652966/1211F). Concomitant therapy included aspirin, "climara", CORGARD, PREVACID and SYNTHYROID. On 04-FEB-2007 the patient developed a red vesicular rash on her right cheek. She had an appointment on 05-FEB-2007 and was diagnosed with shingles. She has treated with VALTREX 1 gram TID. No laboratory tests were performed. It was reported that the patient had a history of shingles; in December 2004. February 2006 and possibly 30 years ago. At the time of the report, the patient was recovering. Additional information indicated that the patient recovered on 20-FEB-2007. No additional information is expected.
Greater than 35 days between Moderna Covid-19; Patient went to a health screening on and was told there were health issues with his blood; This spontaneous case was reported by an other health care professional and describes the occurrence of BLOOD DISORDER (Patient went to a health screening on and was told there were health issues with his blood) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced BLOOD DISORDER (Patient went to a health screening on and was told there were health issues with his blood). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19). At the time of the report, BLOOD DISORDER (Patient went to a health screening on and was told there were health issues with his blood) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2022, Investigation: abnormal (abnormal) health issues with his blood.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Extreme joint pain in every joint possible, from toes to top of head. Lasted 24 hrs. Then low grade fever around 99 to 100 for 12 hrs. Then nausea but only lasted couple hrs. Then weakness that lasted over a2 weeks. Slight rash across right foot toes only for a week with no problems. After a week started burning and put cortisone on it for a couple days which seems to help. Rash went away but burning still there.
Right armpit has swelling; about the size of a potato. Affected area is not sore to touch, not inflamed and is more noticeable when arm is raised over head. With arm in lowered position you feel the area, but there is no pain.
3 days after vaccination with COVID-19 Janssen, patient developed acute right leg pain and swelling. She did not present to the office until 5/11/2021. She was sent to the ER which showing extensive acute DVT and bilateral pulmonary embolism.
This spontaneous report was received from a registered nurse concerning a patient of unknown demographics. On 26-DEC-2013, the patient was vaccinated with VARIVAX (Merck) 0.5 ml, subcutaneously instead of ZOSTERVAX 19400 PFU as prescribed. No adverse effects were reported. Outcome of the event and causality assessment was not provided. Additional information has been requested.
Patient was mistakenly given PCV13 instead of Pneumo 23. PCV13 given on 05/19/15 and again on 02/09/16.
FLUZONE Influenza Virus Vaccine administered at 2:50pm on 9/19/2011, at 8:00pm pt c/o "very weak, tired, body aches, joints hurt & headache". Temperature at 9pm was 99.9, HR 125 from 8pm-12:30am. States she had taken MOTRIN "2 tabs" at 11:30pm. Fell asleep at 12:30am. Also states she had c/o "dizziness". States on 9/20/11 at 1:45pm she feels "tingling to left fingers 2-5".
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 4) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in August 2018, Graves' disease in March 2020 and Alcohol use (2glasses of wine every month.) in July 2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Breast feeding.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in July 2020 and the estimated date of delivery was 12-Apr-2021. On 17-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 17-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2020, Pregnancy: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment was not provided.  Estimated date of conception was reported in Jul-2020. Number of previous pregnancies reported were 3 from which one resulted as spontaneous abortion via miscarriage in Aug-2018.
muscle pain and spasms throughout body about 14 hrs after injection, fever and chills x 1 day, injection site soreness
Localized pain at injection site after injection (12/27/22) Flu-like symptoms (per patient on 1/19/23)
Extremely ill; Diarrhea; Could not eat, Could not drink anything; first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely ill), DIARRHOEA (Diarrhea), FEEDING DISORDER (Could not eat, Could not drink anything), PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose) and VOMITING (Vomiting) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Inflammation (Taking Ilaris (Biologic Medicine) for inflammation. She has a gene that causes inflammation). Concomitant products included CANAKINUMAB (ILARIS) for Inflammation.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced ILLNESS (Extremely ill), DIARRHOEA (Diarrhea), FEEDING DISORDER (Could not eat, Could not drink anything), PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose) and VOMITING (Vomiting). On 11-Mar-2021, ILLNESS (Extremely ill), DIARRHOEA (Diarrhea), FEEDING DISORDER (Could not eat, Could not drink anything) and VOMITING (Vomiting) outcome was unknown. At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine on 05MAR2021, Afraid of taking the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) She states that she did not contact her doctor..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.  She states that she is afraid of taking the second dose.  Consent received for safety to follow up with the patient (Prefers Email).
pt recvd vax;acute retrobulbar neuritis w/ loss of upper visual field,progressing to loss of central vision;
This spontaneous report was received from a 30 year old female patient referring to herself. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On an unspecified date, in September 2018 the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. No adverse reaction was reported.
Non-stop screaming, wailing, inability to console through the entire night (4-5 hours)
my mom received the first dose / had a very severe headache; itchy / arm / several days after the shot.; swollen arm / several days after the shot.; This case was reported by a consumer via ( Chatbot) interactive digital media and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, itchy upper limbs and swelling arm. On an unknown date, the outcome of the headache was unknown and the outcome of the itchy upper limbs and swelling arm were recovered/resolved.   It was unknown if the reporter considered the headache, itchy upper limbs and swelling arm to be related to Shingrix.  Additional details was reported as follows: The patient reported for her mother. The age at vaccination was not reported. The patient received Shingrix and experienced severe headache and itchy swollen arm. The arm was swollen and itchy for several days. The reporter was wondering about the data on the effectiveness of only receiving one dose.
This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medications were not reported. On 19-NOV-2015, the patient received an expired dose of PNEUMOVAX23 injection, lot # K005402, expiration date: 07-NOV-2015 (dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Additional information has been requested.
Employee received Tdap and MMR on 3/12/07. Complained of soreness and redness to area starting that evening. 120 mmx70mm erythemic area with induration.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent condition, medical history or concomitant medications were reported. On 14-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 72 hours and the lowest recorded temperature reported was 33 Fahrenheit (F) (0.555555556Celsius(C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
I was asked by our WIC lady to give vaccines to a child. She gave me pt's name and record states "Just come get her when your ready". So I researched vaccines due. Told them I was ready & father brought in the other child I was unaware of.
The patient has not experienced any known adverse events.  The vaccine that was administered to the patient was improperly stored in the freezer and also administered by the beyond use date of the vaccine.
After receiving the COVID vaccine, the patient was instructed to have a sit in the clinic for 15 minutes in order to be monitored for any adverse reactions. Within that time period, the other patients in the waiting area reported to the staff that the patient has fainted. The patient woke up shortly after fainting. He was visibly pale but he confirmed that he is okay and not in distress (no difficulty breathing, etc). He reported that he's fainted before after a vaccination due to nerves. We gave him some water to drink and had him stay for another 30 minutes so we can monitor him closely. After 30 minutes, we determined that he's well enough to leave the store and no other further care was needed at the time.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 20-MAR-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 22-JUL-2014, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
The pt experienced a fever, stiff joints, insomnia, severe back and leg pain, dizziness and blurred vision. No treatment was required.  A follow up report received 1/8/2001 adds: Update per phone call from pt: states he is getting worse in that he has trouble walking and has a good deal of pain in feet, legs, knees, and now hips. He is concerned because the symptoms are "moving upwards" and he plays piano. These symptoms are "unlike Lyme Disease". The antibiotic tx did help decrease the fatigue and dizziness about 50%. He has no fever or sweats, but still has blurred vision. He remains on Voltarin and also takes glucosamine and milk thistle (homeopathic treatment from nutritionist). He has consulted with a specialist in Lyme Disease who believes he did have Lyme Disease for about 9 months with minor symptoms of slightly stiff neck and occasional fever. The tests for Lyme came back negative then positive s/p first dose of vaccine. He then had two positive testings s/p dose two of vaccine.  Follow up 10/30/2000: "Patient does not know lot #."
Pain and swelling to injection site plus vertigo with Heachache. Motrin, Tylenol and Meclizine.