chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called Health Dept 3/2/2021 at 9:30 am reporting reactions after receiving first Moderna vaccine on 2/26/21.  Patient received vaccine at approximately 10:20 am on 2/26/21.  She reports that a few minutes after receiving vaccine that her throat felt really dry.  It felt 'like when you wake up from anesthesia'.  She had no breathing problems so she didn't think much of it.  About an hour after receiving vaccine,  she went through a drive thru to order food and 'wasn't thinking right, like I had brain fog'.  That lasted a short time.  About an hour after receiving vaccine, patient noticed lips and mouth were tingling 'like I had ate something really spicy'.  This lasted off an on for about an hour.  Later that evening, patient felt dizzy and nauseated.  She laid down and took a nap and woke up feeling better.  Skin started to feel itchy that night.  On 2/27/21, patient woke up with an itchy rash all over back.  Rash is still there.  No other symptoms at this time.
The pt developed a localized area of induration at the shot site approximately 10 cm and mild lymphadenopathy at her axilla. She was seen in f/u on 4/7/16 and prescribed OMNICEF. On 4/9/16 she went to the ER for tightness in her throat. The ER diagnosed an allergic reaction to immunization. No respiratory distress.
pt recvd vax 25FEB94 & 14MAR93 devel enlarged lymph nodes on clavicle, arm & groin; also exp chest pain & arm pain; presented to MD following day w/diffused generalized lymphadenopathy; dx hodgkin's disease;
Pregnant:Yes; COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 10Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient is expected to deliver a baby(s) on 01Feb2023. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Drug Allergy"; Amoxicillin, reaction(s): "Hives". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "Pregnant:Yes". Therapeutic measures were taken as a result of covid-19. Clinical course: Rebound of covid symptoms 9 days after initial onset. Initial symptoms mild (aches, fatigue), rebound symptoms more severe including sore throat, productive cough, nasal congestion, aches, fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diaphoretic, pale around mouth, face.  Complained of nausea and feeling warm and sweaty.  Blood pressure 96/52, heart rate 82 - remain stable.
on half dose received; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (on half dose received) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (on half dose received). At the time of the report, ACCIDENTAL UNDERDOSE (on half dose received) had resolved.        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.
pt recv vax 15MAY95 & 6 hrs later devel full-blown chickenpox; No further details were provided;
Chief complaint of chest discomfort following COVID shot. Office visit. This visit was within 6 weeks of receiving the COVID vaccine.
Covid arm; Arm started to hurt; Got itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PAIN (Arm started to hurt ) and VACCINATION SITE PRURITUS (Got itchy) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039H21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder, Rheumatoid arthritis and Fibromyalgia.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PAIN (Arm started to hurt ) and VACCINATION SITE PRURITUS (Got itchy). At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PAIN (Arm started to hurt ) and VACCINATION SITE PRURITUS (Got itchy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
Patient's mother is not sure when exactly the redness on left thigh started, if it was right after getting the vaccines or if it was later. She sent a message because she thought that the area looked more red and raised today than it had been yesterday or previously. Area on left thigh is about 0.5 inches by 0.25 in size. Pt didn't seem bothered by having the area touched. Pt had a low grade fever of 100 F overnight on 2/15/19. Later on Friday 2/15/19, Patient developed a fever and was fussy/irritable. Then developed rash all over body concomitant with the fever. Fever lasted about 24 hours. Today, 2/18/19 rash is fading but still present on chest/abdomen. Flat (macular) erythematous rash noted on abdomen and anterior chest. Left anterior thigh there is erythema without increased warmth or drainage. Patient noted to be scratching at area during exam. Size of erythema is 1-1.5 cm length, centrally there is induration ~ 5 mm size. No apparent Thrombotic Thrombocytopenia Purpura. Parent instructed to apply hydrocortisone cream to red area on left thigh twice daily for up to 14 days.
second case of "Moderna Arm" after her second dose in her left arm; salmon colored rash which itches.; rash gets better and then flares up again; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (second case of "Moderna Arm" after her second dose in her left arm), RASH PRURITIC (salmon colored rash which itches.) and RASH (rash gets better and then flares up again) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION COMPLICATION (second case of "Moderna Arm" after her second dose in her left arm), RASH PRURITIC (salmon colored rash which itches.) and RASH (rash gets better and then flares up again). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and TRIAMCINOLONE ACETONIDE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (second case of "Moderna Arm" after her second dose in her left arm), RASH PRURITIC (salmon colored rash which itches.) and RASH (rash gets better and then flares up again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2022-485571, MOD-2022-485647 (Patient Link).
Headache, nausea, fatigue, seeing white with eyes closed, unexplained emotional episode (10 minutes) of crying and uncontrollable shaking/psoas tremors
There is a 1 cm pink area where the vaccine was injected and distal to that a 4-5 cm diameter pink warm area. Larger new reaction that is not.
racing heart; 101 Fever; aches; fatigue; chills; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 18:30 (Batch/Lot Number: EL9266) at a SINGLE DOSE for COVID-19 immunisation. Medical history included bronchiecstasis from an unknown date and unknown if ongoing, patient had COVID-19 prior vaccination. Concomitant medication(s) included progesterone, estradiol, acetylsalicylic acid (BABY ASPIRIN) and zn [zinc] (ZN [ZINC]). The patient previously had allergy to thimerasol which is preservative in shots. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021 12:00, the patient experienced racing heart, 101 fever, aches, fatigue and chills. The events were considered as non-serious. No treatment was given for the event. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of all the events was not recovered.
Information has been received from a medical assistant concerning a 9 weeks old patient "2 months old", who on 08-OCT-2010 was vaccinated subcutaneously with a 0.5mL dose of MMR II (Lot # 0407z; expiration date 18-MAR-2012). The patient was not experiencing any known symptoms. Follow up information has been received from a medical assistant. It was reported that on 08-OCT-2010 the currently 3 month old patient was vaccinated IM in the upper right thigh with the first dose of MMR II (Lot number 667243/0407Z). The medical assistant reported that the mother was concerned about the baby developing a rash after the shot was given. The patient's mother did not want the baby to be seen by the office. It was reported that the rash went away. There were no other reactions. No further information is expected.
Patient received flu vaccination in left arm.  Immediately began itching within a few minutes....the next day arm began to be red. She didn't take anything and let it run its course.  She asked what strains the flu vaccine covered and I gave her the information and mailed her a copy.
No additional AEs; An HCP is reporting an AE on behalf of a patient. The caller reports that a patient was administered a dose of PROQUAD after its labeled expiry date. No additional AE details were provided and no additional AE's were reported. No PQC.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 13-DEC-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at a dose of 0.5 mL (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number U017140, with an expiration date of 28-NOV-2022) administered for prophylaxis (expired vaccine used). No additional adverse event (AE) or product quality complaint (PQC) were reported.
Patient with evolving liver failure on oral steroids, Budesonide 6 mg PO OD, being prepped for transplant. Not previously vaccinated against VZV (parental preference). VZV vaccine required by transplant protocol presented to hospital 2/27 with abdominal pain, fever and rash that appeared classic varicella. No wild type exposure. IV acyclovir required.
Initial information received on 12-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff). It was reported that five week old male patient receiving MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). It was a case of actual medication error due to inappropriate age at vaccine administration. Other relevant tests included: On 06-Jan-2019 the five week old male patient has received one skin integrity check which he passed and is scheduled for his second skin integrity check on 12-Feb-2019. No adverse event was reported. 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. List of documents held by sender: none.
Patient states to have had headache, fever, malaise, noticed swelling in knees and joints, stated to have intense pain from 2/24/21-2/26/21, stated to take hydrocodone and muscle relaxants for pain, states that s/s have subsided
Sore at injection spot after 1st shot for about 1 hour.   Sore arm from elbow to shoulder from 5 hours after 2nd shot. Continued for about 24 hours. site of injection was red and size of a quarter.
This case was reported by a physician via call center representative and described the occurrence of chills in a elderly male patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of injection site swelling (For tolerance to 1st dose, refer case US2018076487). Concomitant products included atorvastatin, AMBIEN, clonazepam and LEXAPRO. In April 2018, the patient received the 2nd dose of SHINGRIX .5 ml. In April 2018, less than a month after receiving SHINGRIX, the patient experienced chills, general body pain and fever. On an unknown date, the outcome of the chills, general body pain and fever were recovered/resolved. The reporter considered the chills, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired physician who reported for himself. This case was previously reported to a doctor. The age at the vaccination was not reported. The patient received SHINGRIX on the left arm. The patient received the 2nd dose of SHINGRIX about 2 weeks ago. The patient experienced fever, chills and aching all over that lasted almost 3 full days. The patient considered to go to the emergency room (ER) as it was so bad but he waited it out. The patient was unable to provide full demographics of his personal physician.
Expired Dose; Initial Report Received on 07-DEC-2022 and 08-Dec-2022  This is a spontaneous report, received from a Pharmaceutical Procurement Buyer and a Pharmacy Procurement Technician regarding a female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, a dose of HEPLISAV B (Lot #935843, expiration date 08-OCT-2022, NDC # 43528-002-01), was administered   for hepatitis B immunisation.  The dose was reported as being expired when administered.  The reporter indicated that the patient had not reported any other adverse effects.     Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Medical Assistant gave a 4 month old child Hepatitis A vaccine by mistake instead of HIB. Noticed error after vaccine was administered. Quickly notified PCP and patient's mother. Age of patient at time of event: 3 months 23 days.
On 2/2/01, approx. 18:00, feet started to itch, then broke out in "hives" on trunk and right hand started to swell then had hoarseness and "sore" throat. Went to ER at 19:00 and was there until 23:59 and went home. Put on Zantac and Benadryl. Was given IV and shot of Benadryl at 2nd time in ER. (Was at hunting camp, Friday, when reaction occurred. Returned home at midnight after being seen in ER. On 2/3/01, Saturday AM, symptoms of itching, hives and pain and swelling in both hands had returned. He then went to local ER and was seen by ER MD and wife states he was given IV and injection and sent home. Told at both visits to the ER's that it was an allergic reaction to the flu vaccine, as this was all that was different or unusual in his routine. He has had previous flu shots in the past years. He was improved after treatments and pain and swelling started to resolve. No breathing problems. No problems Saturday or Sunday. On Monday, 2/5/01, at approx. 07:00, had started to complain of pain and swelling in right hand and left hand and feet starting to itch again. Experienced "sore throat" and hoarseness again. He went to his local MD and was admitted to the hospital and given Benadryl, Zantac IV and other things "pain meds") He was hospitalized from 2/5/01 until 2/8/01. Discharged on 2/9/01 and told by MD that he had Rheumatoid Arthritis and given Vioxx for pain and given "Z-pack" for inflammation. Wife comes to health unit today, 2/13/01, to inform me of pt's adverse reactions to flu vaccine. He is still having problems. Right hand swollen and pain in right arm. Also, feet have started to itch again as of yesterday. He is not convinced that he has Rheumatoid Arthritis and feels that his symptoms are still related to adverse vaccine reaction. Went to see another doctor for a second opinion and further treatment as he is very uncomfortable. It was suggested that he go to another hospital that has an arthritis clinic. Per annual follow up: Patient has had no more complications from the influenza vaccine from last year. He has not taken any more influenza vaccine as per doctor's order.
Patient is fully vaccinated and boosted. COVID positive on 4/15/2022.57-year-old female presents to the  ED complaining of dizziness.  Patient states that she began experiencing loss of taste and smell last Friday and tested positive for COVID-19 at that time.She states that she began experiencing dizziness with a feeling as though the room is spinning around her.  Patient denies any history of vertigo in the past.  She denies any fever, chills, chest pain, shortness of breath, or body aches.  Patient denies any diplopia, dysphagia, dysarthria, focal weakness, paresthesias, or ataxia. CT head: Motion degraded exam showing no evidence of acute intracranial hemorrhage or midline shift. The patient was seen and evaluated by Neurology, who recommended IV Solu-Medrol, Benadryl, Compazine, and Antivert.  The patient has some improvement and she was cleared for discharge to follow up with primary care doctor and ENT.
accidentally administered 1ml of the vaccine; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (accidentally administered 1ml of the vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (accidentally administered 1ml of the vaccine). At the time of the report, INCORRECT DOSE ADMINISTERED (accidentally administered 1ml of the vaccine) outcome was unknown. Not Provided      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 drugs included no treatment drugs included   This case was linked to MOD21-082152, US-MODERNATX, INC.-MOD-2021-090288, US-MODERNATX, INC.-MOD-2021-090426, US-MODERNATX, INC.-MOD-2021-090625 (E2B Linked Report).; Sender's Comments:  MOD21-082152: US-MODERNATX, INC.-MOD-2021-090288: US-MODERNATX, INC.-MOD-2021-090426: US-MODERNATX, INC.-MOD-2021-090625:
Little red bumps all over the arms, torso, thighs and back of knees. Bumps were extremely itchy and got worse with time.
I got my vaccine on 1/5/2020 about 7:30AM. Within 5 minutes I felt dizzy, dizziness continued. My arm was very sore-felt hot and like someone punched me. Within 1 hour I had a headache (migraine) that continued from the onset until 6PM 1/6/2020. I felt unwell, malaise, and lightheaded, flu-like for this time period. I experienced muscle stiffness and soreness from the top of my head, down the left side of my neck, down my arm to the elbow on my left side. This continued for about 3 days.
Patient complains of rash. It began 3 days ago. The symptom onset was sudden. Associated symptoms include rash. He denies chills, cough, diarrhea, headache, nausea, sore throat, sweats or vomiting. He did received his 1 year immunizations 1 week prior. Mother states she thinks he had 2 small areas of the rash the day he received the immunization. The rash continued to worsen over the past 24 hours. He has been asymptomatic. No sick contacts. No outdoor exposure. No recent medications.
12/26/2003: chicken pox mild, fever, rash, trunk, neck, forehead, itchy, 5-7 days. 11/16/2004: shingles, rash painful, left breast to mid back and Motrin 600 mg q 6 hoiurs.
abrupt dizziness; light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (abrupt dizziness) and DIZZINESS (light headed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIZZINESS (abrupt dizziness) and DIZZINESS (light headed). At the time of the report, DIZZINESS (abrupt dizziness) and DIZZINESS (light headed) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 17-AUG-2017, the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, frequency, route and indication not reported, lot # M037015 with expiration date 22-NOV-2017) reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # M035268 with expiration date 19-APR-2019). Temperature that the vaccine exposed to was 40.2 F, the time frame was unknown. There was a previous temperature excursion of 15 F to 46 F for 18 hours and 34 minutes. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1708USA012218: US-009507513-1709USA007623.