chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site warmth; Vaccination site rash; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE RASH (Vaccination site rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included GLIPIZIDE, LISINOPRIL, METFORMIN, SIMVASTATIN, VERAPAMIL HYDROCHLORIDE (ISOPTIN DC) and AMLODIPINE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE RASH (Vaccination site rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Vaccination site warmth) and VACCINATION SITE RASH (Vaccination site rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included ice application.
throat closed,  left side face and neck swollen, fever, chills, nausea, throwing up, muscle pain, joint pain, fatique
Left arm tingling and numbness from hand to shoulder.  Aching.  No injection site redness or swelling.  No palsy or other symptoms.  Symptoms began on Day 10 post injection and continue.  Had brief, faint chest pains last night, 4/12, while walking to car after restaurant prepared sea bass meal.  This morning my arm is tingling and aches like it has been slept on or is not receiving proper blood flow.  Right arm is fine.  BP normal.  Breathing normal.  No other issues.
Sharp stomach pains for approximately 24 hours after taking the 1st Typhoid pill.
pt ran fever from 27JUN to 30JUN @ one point 28JUN it was 103.8
This case was reported in a literature article and described the occurrence of chronic inflammatory demyelinating polyneuropathy in a 12-year-old subject of unspecified gender who was vaccinated with Hepatitis A vaccine (manufacturer unspecified), DTPa (with small D + P) and meningococcal acwy vaccine (non-gsk). On an unspecified date, the subject received an unspecified dose of Hepatitis A vaccine (administration site and route unknown, batch number not provided), an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided) and an unspecified dose of Meningococcal ACWY vaccine (Non-GSK) (unknown). Less than 21 days after vaccination with DTPA (with small D + P), Hepatitis A vaccine and Meningococcal ACWY vaccine (Non-GSK), the subject experienced chronic inflammatory demyelinating polyneuropathy. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The author considered the event was possibly related to vaccination with Hepatitis A vaccine, DTPA (with small D + P) and Meningococcal ACWY vaccine (Non-GSK). This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. The author's conclusion stated that the CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
Dizzy, lightheaded, rapid heart rate and swelling in throat.  Benadryl taken.  In August admitted to ICU and diagnosis of DKA.  In hospital for 3 days.  Then in November very high elevated liver enzymes with no etiology.  Continuing to this day with unremarkable liver biopsy results and lab work.  No history of diabetes- type 1 or liver disease and now to this date still have elevated liver enzymes and joint pain
immediately projectile vomited; This initial spontaneous report was received from a nurse refers concerning a 2 month and 5 days old infant female patient. The patient's pertinent medical history, concurrent conditions, allergy drugs/drug reactions and concomitant medications were not reported.  On 15-NOV-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), per oral route, Lot # reported as 168825 and expiration date 24-NOV-2021 (strength, dose and frequency not provided) for prophylaxis.         It was reported that on the same day, on 15-NOV-2021, the patient immediately projectile vomited after receiving the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). It was reported that the patient did not seek medical attention. No additional events were reported.   The outcome of vomiting projectile was reported as recovered/resolved on 15-NOV-2021.     The causal relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown at the time of the report.  Lot Number 168825 is invalid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and does not match any company product as confirmed by Lot Verification team.
Diarrhea; red throat with tiny pustules; red throat with tiny pustules; Dry throat; hoarse voice; yellowish-green dry mucus on her nose; chest pain; pressure on her upper back and chest/feels like something large in her windpipe/chest like oppressed; heart palpitations; swelling at the extremities; pressure on her upper back; seldom cough  (dry throat that makes you cough almost like allergy); fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PHARYNGEAL ERYTHEMA (red throat with tiny pustules), PHARYNGEAL PUSTULE (red throat with tiny pustules), DRY THROAT (Dry throat) and DYSPHONIA (hoarse voice) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PHARYNGEAL ERYTHEMA (red throat with tiny pustules), PHARYNGEAL PUSTULE (red throat with tiny pustules), DRY THROAT (Dry throat), DYSPHONIA (hoarse voice), NASAL MUCOSAL DISCOLOURATION (yellowish-green dry mucus on her nose), CHEST PAIN (chest pain), CHEST DISCOMFORT (pressure on her upper back and chest/feels like something large in her windpipe/chest like oppressed), PALPITATIONS (heart palpitations), PERIPHERAL SWELLING (swelling at the extremities), MUSCULOSKELETAL DISCOMFORT (pressure on her upper back), COUGH (seldom cough  (dry throat that makes you cough almost like allergy)) and FATIGUE (fatigue). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form and ATTAPULGITE, CALCIUM CARBONATE, SULFAMETHOXAZOLE, TRIMETHOPRIM (DIAZOL [ATTAPULGITE;CALCIUM CARBONATE;SULFAMETHOXAZOLE;TRIMETHOPRIM]) for Adverse event, at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea), PHARYNGEAL ERYTHEMA (red throat with tiny pustules), PHARYNGEAL PUSTULE (red throat with tiny pustules), DRY THROAT (Dry throat), DYSPHONIA (hoarse voice), NASAL MUCOSAL DISCOLOURATION (yellowish-green dry mucus on her nose), CHEST PAIN (chest pain), CHEST DISCOMFORT (pressure on her upper back and chest/feels like something large in her windpipe/chest like oppressed), PALPITATIONS (heart palpitations), PERIPHERAL SWELLING (swelling at the extremities), MUSCULOSKELETAL DISCOMFORT (pressure on her upper back), COUGH (seldom cough  (dry throat that makes you cough almost like allergy)) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she visited ER and checked her lab, tomography and EKG (ie. discarded pulmonary embolism, myocarditis)  Patient stated that she was planning to become pregnant but was not currently trying.
Fever, Wheezing, Tightness in Chest, trouble breathing, fast heart beat, weakness, numbness and tingling, chest pain, shortness of breath, heart pounding.
Medical Assistant vaccinated using a dose that had been out of the refrigerator more than 6 hours as indicated by Manufacturer.  We have been in contact with family and child feels completely fine. We did contact Pfizer to find out how soon he would need to be revaccinated if at all. Still awaiting their recommendation.
Severe fatigue and had all of the symptoms of Covid and they were gone by 24 hours. Had a miscarriage in my first trimester.
This spontaneous report was received from a Certified Medical Assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 22-SEP-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N011867 with expiration date on 08-NOV-2018 (anatomical route of vaccination was not provided) for prophylaxis. It was also reported that, PNEUMOVAX 23, was exposed to a temperature of 70 °F for a 120 hours time frame. The above mentioned vaccine, was not involve in any previous temperature excursion and the call was not made due to a data logger. Furthermore, no adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA014851: US-009507513-1709USA014898.
Reported (L) arm red & swollen without c/o pain 2 days post vaccination.
About 6-7 hours after the vaccine, started feeling fatigue. 12 hours after woke up with a fever, body sweats, headache, body ache and sore injection site. This lasted for about 24 hours from when I first started feeling bad. Today (about 40 hours after the vaccine) I still feel a little sore and tired but much better than yesterday.  Injection site is still very sore.
Cellulitis reported by patient and ER physician. Cephalexin was prescribed by the ER physician.
1 hr after left deltoid injection, patient developed numbness and tingling of the left han. Finger 4th and 5th soon after that noticed metalic taste on his mouth with slight light headedness on left. Also tingling on the (Rt) ear that now went away.
A bumpy rash appeared on my face, down my neck and onto my torso; later, tiny red spots appeared all over my chest. This went away after about 2 days.
Fever, chills, nausea started around 5pm.  Fever, chills, severe joint pain, pain when walking - especially stairs, headache, lethargy
Information has been received on 13-APR-2018 from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-FEB-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-MAY-2016, the patient was treated for a persistent vesicular rash, which was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
My arm began to feel sore roughly 6 hours after injection. Around 10pm, I took Tylenol and went to bed but had a tough time sleeping; I recall waking just after midnight soaking wet from sweat (abnormal for me). In the morning, I woke with a bad headache and sore arm so I took ibuprofen which seemed to work well; had the day off from work so took it easy all day. Went to bed early that night and slept a little better, but woke the next morning to a very sore injection site and swollen lymph nodes in the left armpit. I went to work on the second day after receiving the booster and felt poorly hard to pinpoint any main complaint, but felt pain in my shoulders, stomach pains, headache, fever, off and on chills, fatigue, and nauseous; I went to bed around 9pm last night and again suffered from night sweats. At the point of writing this information, it is the start of the third day after receiving the booster and my main complaint is of swollen lymph nodes under the left arm; there is also some mild pain at the injection site and an occasional headache. I have not notified a doctor at all since my husband and I are both dealing with similar side effects. From everything I have heard from others who received this booster, or been able to find online, we have not experienced anything abnormal. I would just like to mention that Pfizer's 3rd dose has had the most negative effects on myself and my husband; we are both healthy, with no underlying health concerns, and have not had Covid-19 to our knowledge.
injection site was swollen; has a rash on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site was swollen) and VACCINATION SITE RASH (has a rash on the arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE SWELLING (injection site was swollen) and VACCINATION SITE RASH (has a rash on the arm). At the time of the report, VACCINATION SITE SWELLING (injection site was swollen) and VACCINATION SITE RASH (has a rash on the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included None.
Fevers, irritability, temper tantrums, poor feeding, scratching himself, biting, not sleeping well.
Random bouts of hearing loss followed by loud ringing in the ear. It subsides fairly quickly but has happened 3 times in less then 24 hrs of receiving the shot.  Never dealt with this before
pt recvd vax 330PM started itching 30-min later reported to urgent care scratiching all over mild erythema, a few urticarial patches on hands;susphrine-Pred
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 05-SEP-2014, the patient was vaccinated with a expired dose of ZOSTAVAX lot # J011211, expiration date 31-JUL-2014. Dose and route was not reported. No symptoms reported. Additional information has been requested.
Gave vaccine about 12:40pm and patient had reaction within about 30 seconds. He said he was nervous. I went to get cold water and a cool pack for him. On the way back He was leaning over. Our tech and I helped him. He then said his throat was closing and then he started struggling to breathe and his arms looked red and rashed. Gave dose of Epipen in left thigh and had tech call 911. His breathing got easier (just fast) Then said he felt like he was going to throw up (he did not) EMTs arrived about 1:07pm and checked him out and said everything 100%. His wife got him some food and he sat in waiting area for a bit and then was able to walk away. Did not go to hospital. EMTsaid probably not an allergic reaction just fright of having vaccine. He was smiling and laughing a bit by the time he left
UPPER RESPIRATORY INFECTION; MIGRAINE HEADACHES; EXTREME FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered on 07-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced upper respiratory infection, migraine headaches, and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme fatigue, and the outcome of migraine headaches and upper respiratory infection was not reported. This report was non-serious.; Sender's Comments: V.0 Medical assessment comment not required as per standard procedure as case was assessed as non-serious.
For item 17 - Dose on form says 0.5 ml. Directly after injection and through the evening/night and all of the following day, injection site was very sore with a very mildly raised and hardened feel and lightly tinted red color about 2" in diameter. 2/23/2019 - Cluster seizures: 7:45 am - 5 second facial seizure. 7:46 am - 87.5 mg of Lamotrigine and 180 mg of Oxcarbazepine administered. 7:50 am - 15 second facial seizure. 7:51 am - 30 second facial seizure. 8:20 am - 20 second facial seizure. 8:29 am - 3 minute facial seizure (some weakness in legs/arms). 9:11 am - 5 second facial seizure. 9:28 am - absence seizure of unknown length - no outward signs of seizure but he urinated while sitting on the couch. 10:30 am - 0.25 Clonazepam administered. No further seizures.
This spontaneous report has been received from a Registered Nurse concerning an unknown number of patients of unspecified age and gender. Concurrent conditions and pertinent medical history of the patients were not reported. On an unknown date, the patients were vaccinated with GARDASIL, intramuscular injection, (strength not provided), 0.5 ml, once, (dose in series unspecified), that were improperly stored. The reporting nurse stated that she did not have patient details including dates of administration. Additionally, the lot numbers and expiration dates of GARDASIL were provided: (Lot # K008213, expiration date on 17-DEC-2016), (Lot # K009482, expiration date on 06-MAR-2017), (Lot # K007828, expiration date on 02-MAR-2017). There was not adverse effects reported. Additional information has been requested.
Swelling of the supraclavicular lymph node on left side, ongoing but getting smaller since injection. Less prominent swelling of lymph node under jaw and arm pit on the same side as the injection.
This spontaneous report refers to a possible 9 patients of unknown ages. The patients were vaccinated with improperly stored doses of GARDASIL (Lot # not reported) from October 2012 to December 2012. The patients were not experiencing any known symptoms. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. No further information is available.
48 post-vaccination was noted to have a 4.5 x 6 cm area of erythema and induration at injection site. No fever, area tender to touch. Tx's with ice to area and Tylenol every 4-6 prn. Call back
had a stroke; This is a spontaneous case from a contactable consumer (patient). This 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via unspecified route in left arm on Apr2021 at 11:00 AM at patient age of 60-year-old, as single dose (Lot Number: ER8735) for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient medical history was none. The patient had none known allergies. The patient concomitant medications included hydrochlorothiazide, acetylsalicylic acid (ASPIRIN), cetirizine hydrochloride (ZYRTEC). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via unspecified route in left arm on Mar2021 at 11:00 AM at patient age of 60-year-old, as single dose (Lot Number: EP7533) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a stroke on 25Apr2021 17:00 PM. He had no idea whether this was a coincidence or was connected to the shot. However, due to the proximity in time to the second covid shot, the patient thought that this event might be related. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization for 3 days. The patient did not receive treatment. COVID not tested post vaccination. The patient recovered from the event in 2021.   Follow-up attempts are completed. No further information is expected.
pt recvd vax & 1wk later exp t101 & eating poorly; adm to hosp 9DEC94 w/probable otitis, & r/o sepsis; pt was placed on ATB (ampicillin & Cefotaxime) x 2 days; MD feels that fever was in temporal assoc w/vax; an upper resp infect (poss OM)
Patient experienced hives, head congestion and runny nose 4 days after receiving preservative free FLUZONE and Tdap vaccines.
RECEIVED AN EXPIRED  DOSE OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced received an expired dose of the janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received an expired dose of the janssen covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20210944792 and 20210943969.
Patient phoned to say had a rxn size of silver dollar at injection site. Instructed her to see dr. Patient came in and had rx for ALLEGRA & Triamcinolone cream and also stated dr gave her a steroid shot. Pt stated she had no fever.