chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 16Mar2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the COVID-19 vaccine manufactured by Pfizer on Tuesday (16Mar2021), and on Tuesday night (16Mar2021) he started to have some reactions (unspecified) that he thought could be related to the vaccine. At the day of the report, 18Mar2021, he tested positive for COVID-19. He has an appointment for his second dose in 3 weeks. He wants to know if he can receive the second dose of the vaccine if he tested positive for the COVID-19 infection after the first dose. He also wants to know if the second shot might have milder side effects since he already had his first shot. Outcome of the event was unknown.   Information about lot and batch number was requested.
Tingling & numbness in fingers & toes; blood work, EMG, MRI;
dizziness; her body hurts a little bit; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on [21Apr2021], this case now contains all required information to be considered valid.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose: 1), for COVID-19 immunisation.  The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; PAIN (non-serious), outcome "unknown", described as "her body hurts a little bit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in case numbers 2014SA071253, 2014SA071260, 2014SA071262, 2014SA071266, 2014SA071268. A 16 year-old patient had received ADACEL and/or DAPTACEL and developed a mild cough. The patient tested PCR positive for pertussis. According to the reporter, there was an outbreak of pertussis in the county where the patient resided. Outcome was not reported. Note: The patient's gender, date of birth, date of vaccination, date of event onset, vaccine lot number, route and site of administration were not reported. Documents held by sender: none.
Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover/Potential sub potent dose.; Does not monitor freezer temperatures/Possible freezer temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover/Potential sub potent dose.) and POOR QUALITY PRODUCT ADMINISTERED (Does not monitor freezer temperatures/Possible freezer temperature excursion) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     It was unknown  if patient had ever been diagnosed with/ tested positive for COVID-19.     On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Does not monitor freezer temperatures/Possible freezer temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover/Potential sub potent dose.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover/Potential sub potent dose.) and POOR QUALITY PRODUCT ADMINISTERED (Does not monitor freezer temperatures/Possible freezer temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Does not monitor freezer temperatures/Possible freezer temperature excursion) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was vaccinated from vials originally stored in freezer / potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover/Potential sub potent dose.).    No concomitant medications were reported  It was reported that vaccines was stored, there was no monitoring of  the freezer temperature and those vaccines was administered to patients. Vaccination site has a data logger, but it was not set up to record.  The HCP stated that there is no freezer minimum and maximum temperatures to report as the temperatures are not recorded by the site.  There were no adverse event, only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover. The event did not cause the patient to seek medical care.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Live Follow-up received contain non significant information Quality complaint number received.
Slight itch in throat after vaccine; Slight cough. Thought cough was due to pollen in air.; As evening progressed, slight itching of fingers, toes, and top of head.; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 16:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included acid reflux, chronic sinus infection, tree/grass/dust pollen allergies. The patient previously took sulfa drugs and experienced allergy. Past has allergy to raw onions and green beans. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), atorvastatin calcium (LIPITOR), cetirizine (MANUFACTURER UNKNOWN) and other unspecified medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 17:00 the patient experienced slight itch in throat after vaccine and slight cough. The patient thought cough was due to pollen in air. As evening progressed, the patient experienced slight itching on fingers, toes, and top of head. The patient took diphenhydramine hydrochloride (BENADRYL) for events before going to bed. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events was recovered on 07Apr2021.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added medical history tree allergies.
Patient is a 39yo female s/p full Moderna COVID vaccination: dose 1 on 1/7 and dose 2 on 2/4. Patient is physician at this institution. Exposure to COVID-19 on 7/15. Symptoms reported include cough. PCR test ordered on 7/26 resulted back positive.
Breakthrough COVID-19 case with symptom onset 8/31/2021:  Chills,  Muscle or body aches,  Runny nose/Congestion,  Cough (new onset or worsening of chronic cough),  Shortness of breath or difficulty breathing,  Fatigue or tiredness,  Nausea or vomiting,   Abdominal pain, and ringing in the ears. Patient started feeling very unwell on the first day with heavy coughing, congestion, ears were ringing, and had some pain in the diaphragm. On the first, went into the hospital because they were having trouble getting full breaths in and the other symptoms had not gone away. They cam back same she had evidence of pneumonia, a common concurrent illness linked to COVID-19. After receiving medication for the pneumonia, the breathing eased and the cough became less strong. Currently, PUI is at home, and PUI is struggling with nausea from the medications, feeling a little sore, and chills at night, so symptoms have not gone away completely. Hospitalized for 3 days 9/1/2021-9/3/2021.
Pain and stiffness in the upper arms muscles, pain and stiffnes in the muscles around the hip.  Kept getting worse until unable to sleep at night. We were at a spiritual retreat.  Finally saw a doctor there on 11/1/2016 and he gave paracetemol which gives temporary relief.  But as soon as I stop taking, the pain returns.
Pain in calves in days following vaccination along with numbness in legs, temporarily lost feeling in half of face, tingling in mouth and tongue, double vision, vibration sensations in legs. Patient still experiences joint pain, especially in left elbow, left hand left wrist, left shoulder and at injection site, vibration sensations in legs, double vision, muscle pain, was treated for Lyme diagnosis on 02/08/11, am now on Plaquenil (400mg daily) and course of Prednisone for possible rheumatoid arthritis.
About a week after receiving my second dose of Moderna, I had increased muscle and joint pain and also a rash that was mostly over the front and back of my trunk. Around 10 days after the vaccine, I saw my primary care doctor who prescribed a topical medication for the rash which didn't really help. The rash eventually went away on its own, but the muscle and joint pain persisted. He put me on a tapering dose of prednisone which completely helped the joint and muscle pain, but as soon as I got to 5 milligrams the pain came back. My doctor then referred me to a rheumatologist who I saw in September of 2021 who diagnosed me with polymyalgia rheumatica. I am now on 7.5 milligrams of prednisone daily which is helping but the joint pain is getting worse, and I expect to have to go up in my dosage. I was on a higher dosage over the summer and tapered down. I was also diagnosed with Valley fever which I contracted while hiking in February of 2022.
This spontaneous report was received from a Registered Nurse and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates since 14-MAR-2017, the patients were vaccinated with improperly stored ROTATEQ, lot number as reported M038847, expiration date 27-APR-2018, (dose, dose number, route and anatomical location were not reported), for prophylaxis.  The vaccines experienced a temperature excursion between 47 to 77 Fahrenheit Degrees during 30 minutes and previously on an unknown date, during 1 hour between the same temperatures. Digital data logger was involved. No adverse effects were reported. Product quality complain was not involved. No other suspect or concomitant therapies were reported. Additionally, the reporter stated that the "Outcome: all supported". This is one of several reports from the same reporter. Additional information has been requested; Sender's Comments: US-009507513-1703USA012119: US-009507513-1703USA011942: US-009507513-1703USA012118:
Headache, Myalgia & UrticariaPruritus Narrative:  Per nursing report: "took 2nd dose of Moderna vaccine on Thursday 1-28-21. States Friday night while at work c/o left arm swelling, redness, itching, muscle tightness in neck, weakness, and left leg weakness with stiffness. Denies any fever. States feels better today. "
Pt was having nerve pain coming down from vaccinated arm for a week. Relieved with capacasin patches.
The pt received the vaccines on 6/5/00. The Father called the health department on 6/6/00 to report notable swelling of right leg where vax was given. The RN requested that the child be seen by a pediatrician. The MD diagnoses a "local reaction", swelling reported as heavy to calf and mid thigh of right leg. The RN contacted the mother on 6/8/00. The child's leg still described as swollen but decreasing in size. No other symptoms or complications at report date.
FOGGY FEELING, FEELING LIKE TAKEN AN HALLUCINOGENIC; LETHARGIC; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-JUN-2021, the subject experienced foggy feeling, feeling like taken an hallucinogenic. On 15-JUN-2021, the subject experienced lethargic. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from foggy feeling, feeling like taken an hallucinogenic, and lethargic. This report was non-serious. This case, from the same reporter is linked to 20210651147.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Received vaccines 2/20/08. The next night had fever of 102 deg and not feeling well. Took ibuprofen which decreased fever. On 2/20/08 legs started feeling achey and by 2/24/08 they hurt. Reports hurt most in calves of legs. Mother and child reported 8 cm scale of 0-10 for pain. Mother and child shuffled when walked because of pain. Talked to agency somewhere who has a nurse to talk to that nurse thought it should be reported. legs were better on 2/25/08 and now normal. Did take child to Dr. for c/o sore throat and was put on z-pack. Dr 2/25/08
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: APIXABAN taken for cerebrovascular accident prophylaxis; DILTIAZEM HCL taken for hypertension; LOSARTAN taken for hypertension; HYDROCHLORIDE B1; PREVACID; AMBIEN. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional information: This patient developed pancreatitis after receiving apixaban therapy. Based on the etiopathogenesis of pancreatitis, the reported event is considered not related to apixaban. Pfizer is a marketing authorization holder of Thiamine HCl in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Thiamine HCl has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received Adacel in left arm on 7/22/08.  Developed arm pain, redness, induration the next day.  Was seen in the office 7/24/08. Had a 2 cm area on his upper left arm which was tender, red, and indurated.
Pt had flu vaccine 10/8 in AM.  Developed multiple hives all over trunk, arms 10/11 evening.  Treated with BENADRYL - seen in office 10/12/09 with continued hives.  Also was in haymaze over we, had temp 101 on 10/12/09.
Noticed red spot 2-3 days after injection, pain to touch 2-3 cm size, warm and tender 1 blister noted on medial corner of redness. Put on Septra for possible Cellulitis Mom noticed red spot on rt leg 2-3 days ago after vaccines 8 days ago, has gotten slightly bigger and more red, over past 24 hours, today child cries and pulls back whenever it is touched, she had proquad in that leg,
Had 2nd Pfizer vaccine on 4/7/21 and developed left upper chest pain with exertion, and deep breath. Continues to also have ringing in the ears from her first vaccine on 3/13/21. (separate report filed)
fever; tiredness; muscle aches; chills; nausea; This is a spontaneous report from a contactable consumer. A 54-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 25Jan2021 at 10:10 at a single dose on left arm for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. This morning (26Jan2021), when the patient woke up, she had a fever. She was wondering if she would be contagious to her family. Confirmed she is not positive for COVID. She was just wondering if she would be contagious since she had a fever. She has experienced tiredness, muscle aches, fever, chills, and nausea this morning when she woke up. She is a little better at this point. She works at a doctor's office but is not a healthcare provider. The patient received the first dose of BNT162B2, lot number: EJ1686 on an unspecified date. The outcome of the events was recovering.
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with two doses of ROTATEQ (strength, dose, frequency and route were not reported) lot # K023535 with an expiry date of 22-MAY-2016. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.
Patient had numbness and tingling in arm after vaccine. Continued to get worse over the course of the week. Mother took son to doctor after continued to worsen on 10/23/2020. She reported to pharmacy that they had to get multiple x-rays and tests and MD confirmed issue is due to incorrectly given flu vaccine
This spontaneous report as received from a nurse refers to unspecified patients of unknown age. Nurse reported improperly stored PNEUMOVAX23 (dose, route and frequency, lot# were not reported) was inadvertently administered to an unspecified number of patients. No adverse effects reported. This is one of the two reports from the same source. Additional information has been requested.
This spontaneous report as received from a physician refers to a 83 years old female patient with no pertinent medical history. The patient was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX on 31-DEC-2008 (lot# not reported). No other co-suspects were reported. No concomitant medications were reported. On 05-SEP-2012 the patient developed shingles, 1345 days after onset of therapy. The patient sought unspecified medical attention and was treated with acyclovir and prednisone. The outcome of shingles was reported as not recovered/not resolved. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
sob, loss of voice immediately after vaccination. used her own albuterol inh. felt better within 5-10 minutes. no difficulty breathing, tongue swelling, chest pain, headache. bp 130/84, hr 86, O2sat 99
One day post vax, this pt experienced dizziness, feeling of passing out, nausea and tingling of tongue, hands and feet. The pt reportedly has not yet recovered from this experience, still having symptoms. From additional information received on 11/24/98, it was reported that the pt's symptoms resolved on 10/20/98 and that he had a full neurological exam - dizziness not neuro in nature and pressure inner ears wnl, also not cardiac in nature.  Physician felt that it was flu shot reaction, no dizziness/vertigo in past 4 days. Follow up #1 06/28/02: During internal review of all files, it was deemed necessary to amend the report by updating the adverse event coding (added cardiovascular disorder and syncope)
Child was Inadvertently given Meningococcal conjugate vaccine a 2'nd time on 07/18/2008.Child had previously received the vaccine on 11/19/2007.
This initial spontaneous report was received from a 76 year old female patient regarding herself.  Concurrent conditions included thyroid problem for 20 years and high blood pressure for 30 years.  Concomitant medications included an unspecified high blood pressure medication. She was allergic to propoxyphene (DARVON), amoxicillin and clavulanate (AUGMENTIN), and oxycodone hydrochloride (OXYCONTIN). On 08-NOV-2017, the patient received ZOSTAVAX in her right arm  to "avoid shingles" (dose, route, and lot # not provided). On 20-NOV-2017, she visited the Emergency Room (ER) for sharp pains on the left side of her head and a rash on her forehead over her left eye. She had a CT scan in the ER (results not provided). She then saw her primary care physician who confirmed she had shingles and prescribed unspecified antivirals, orphenadrine (K-FLEX) for 10 days, Calamine Plus lotion, and unspecified nerve pain medication. The patient also had an eye examination which revealed that the optic nerve was not affected by the shingles. The patient said that the shingles lasted six weeks and she recovered from the rash and nerve pain but she still has scars oh her forehead from the shingles rash. Causality assessment was not provided.  The patient asked to "submit a claim" regarding her report that she received ZOSTAVAX and developed shingles. Additional information has been requested.
6 x 6 cm, round, area of left deltoid, erythema, induration, warmth, no fever, mild itch, mild pain with palpation.
diarrhea ongoing since she received covid vaccine . Received Janssen vaccine on 04/09/2021. Has been having diarrhea since then for 6 weeks or more. Frequent watery BM. approx 4 episodes/day. Has been hydrating well. Questioning if side effect of vaccine vs a bacterial infection . Unsure if she did vsafe post vaccine. Denies fever. No abdominal pain. No vomiting. No melena or hematochezia. No anorexia or food triggers. No sick contacts. Denies unintentional weight loss.
72 hrs p/vax pt devel a bumpy rash on neck, back, chest & in skin folds in joints both arms; spread to face by day 5; was treated by family MD w/DPH; prescription for Pred; rash is cont to spread on day 7; MD advised pt to d/c rabies series
Initial report was received 11 January 2011 from a health care professional which involved a cluster of two unidentified patients. Two unidentified patients had received ADACEL, lot number 02969BA (lot number invalid) on an unspecified date (route and site of administration not reported), and an unspecified amount of time later, they developed cellulitis. According to the reporter, their supervisor reported these events to the CDC several months ago. No additional information was provided at the time of the report. Documents held by sender: None.
Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Additional Details: Went to Emergency department where he was diagnosed with premature ventricular contractions. He was discharged from ED (not admitted to hospital) and referred to cardiology for follow up.