chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very painful, and our arms (right rear) continues to be very tender and painful 20 hours later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 19:00 (Lot number: FH8027) at the age of 68 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm right, administration date 05Nov2021 (Batch/Lot number: unknown) for immunisation. Relevant medical history included: "Diabetis" (unspecified if ongoing). Concomitant medication(s) included: LANTUS; METFORMIN; EXFORGE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 22Mar2021, when the patient was 68 years old, for COVID-19 Immunization, reaction(s): "first two doses to let to a mild sore shoulder for me"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Location of injection: Arm Left, Vaccine Administration Time: 08:00 PM), administration date: 25Feb2021, when the patient was 67 years old, for COVID-19 Immunization, reaction(s): "first two doses to let to a mild sore shoulder for me". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 05Nov2021 21:00, outcome "not recovered", described as "very painful, and our arms (right rear) continues to be very tender and painful 20 hours later". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The Booster injection  were very painful, and our arms (right rear) continues to be very tender and painful 20 hours later. Also note that we also received our Senior dose Flu shot in the same right (front) arms. This injection site is also a little tender (2 out of 10), but nothing like the Pfizer site (7-8 out of 10). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. The patient had no known allergy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101531728 Same reporter/ drug/ event for different patients
Fever, swelling, redness , pain in both thighs started after vaccination. Seen 8/3/23 in clinic, treated for cellulitis with PO Clindamycin, today at followup call pt improved.
3pm started body aches and fatigue; around 7pm chills, body aches and fever and nausea which lasted until 7 pm the following day;Monday March 15th I had a headache, sore neck and throat hurt when I swallowed; Tuesday I had a rash on the right side of my face. I went to dermatologist on Thursday and she indicated the rash was likely from the vaccine.
A week after injection, arm red, swollen and hot. Took antibotics for several days. Dose increased because swelling was progressing. After 10 days of antibotics, symptoms went away.
Patient is 17 years old and received dose #1 of the Moderna Covid 19 vaccine which is only authorized for patients 18 years and older.  Dose #2 not given. Told to return for second dose in August once 18 years old.
Patient presented to the pharmacy with a small knot and a little redness around the injection site.  She also had a couple of places on her right arm that she had scratched because she said they were itching.
Patient was given Tdap and should have been given DTaP.  According to our pharmacist patient will need to repeat with DTaP and this will count as his 3rd dose. Normal vaccine schedule to resume thereafter.
Nurse  reported to myself and Regional lead  that patient had a seizure at 1617 that lasted 90-120 seconds.  Patient was lethargic but A&O x 4.  Patient's mother reported hx of epilepsy. Vitals were stable at this time. 121/77, 68, 98.8, 100%, 16.  Patient and mother present denied need for EMS to come out. No further reactions were noted at this time.  Patient left in passenger seat with mother driving.
pt recvd vax;lt arm 4.5 x 5.5 cm red & warm area - site of inj;
Following Engerix B vax- pt exp blood shot eyes w/ tearing & swelling @ site of injection w/ redness & was erythematous. Was accompanied by T of 101 which lasted for 24 hrs.
48 hours after vaccination, the mother states a rash to the face, neck then spread to the rest of the body became "welt like", and both eyes were swollen. No difficulty breathing, vomited 1 time. Went to the ER. Temperature of 100.
Information has been received from a pharmacy student concerning a 15 month old female patient with allergy to sesame oil who on 06-MAR-2012, was vaccinated with a dose of VARIVAX (Merck) (dose and route not provided) (lot# 671130/1220AA). There was no concomitant medication. On 21-MAR-2012, the patient developed varicella like rash all over the body along with febrile illness after receiving VARIVAX (Merck). No laboratory tests were performed. The patient was treated with acyclovir. The patient sought medical attention, went to the clinic. At the time of the report, the patient's outcome was unknown. A lot check has been initiated. This is one of several reports received from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot 671130/1220AA conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. Additional information has been requested.
Pt developed a cough and congestion that worsened over 3-4 days. Required physician visit due to chest pain.
Immobile shoulder because of pain being a 10 on scale, slight fever, sick feeling, lasting 48 hours, pain at 7 next day, 4 the third day.
Approx a few hours after receiving the vaccine in my left arm, I developed severe arm pain that progressed into swelling at the injection site (size of tennis ball) that felt warm to touch.  Approx 24 hours post vaccination, I developed fever of approx. 100, chills, malaise, headache.  I was sick in bed for 2 days.  These flu-like  events resolved within 2 days after developing them.  The arm pain began to subside approx. a week post vaccination.
flu-like feeling; body feeling very weak; achy in back and legs; body is not warm, it is more cold; chills/shivering; body aches; headache; felt tired/fatigued; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), BACK PAIN (achy in back and legs), FEELING COLD (body is not warm, it is more cold), INFLUENZA LIKE ILLNESS (flu-like feeling) and ASTHENIA (body feeling very weak) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid disorder. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN [METFORMIN HYDROCHLORIDE]), METOPROLOL TARTRATE (METOPROLOL [METOPROLOL TARTRATE]) and LOVASTATIN for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (felt tired/fatigued). On 20-Mar-2021, the patient experienced PAIN (body aches) and HEADACHE (headache). On 23-Mar-2021, the patient experienced FEELING COLD (body is not warm, it is more cold) and CHILLS (chills/shivering). On an unknown date, the patient experienced BACK PAIN (achy in back and legs), INFLUENZA LIKE ILLNESS (flu-like feeling) and ASTHENIA (body feeling very weak). The patient was treated with PARACETAMOL (TYLENOL) from 23-Mar-2021 to 28-Mar-2021 at an unspecified dose and frequency. At the time of the report, PAIN (body aches), BACK PAIN (achy in back and legs), FEELING COLD (body is not warm, it is more cold), INFLUENZA LIKE ILLNESS (flu-like feeling), ASTHENIA (body feeling very weak), CHILLS (chills/shivering), FATIGUE (felt tired/fatigued) and HEADACHE (headache) outcome was unknown.            Action taken with mRNA-1273 is not applicable
On 06/29/17, 72 yo F was seen in clinic for initial consult. During this visit, pt was ordered to receive IM PREVNAR 13 [IMM78]. Per immunization record, a volume of 0.5 mL was injected at 1058 AM into pt's left deltoid (NDC: 0005-1971-01; Lot #S06823). Pt was then discharged home. At 1822, pt called clinic and reported feeling fatigued described as run down feeling similar to having a cold or flu (pt reported that she napped twice today and felt she could go back to sleep) and forgetfulness (forgot where she put her cat's food). Pt thought this was related to immunization. This call was managed by triage RN. RN documented that the symptoms should be managed at home and "CARE ADVICE given per Immunization Reactions (Adult) guideline." On 07/11, pt sent an e-mail to provider stating "I had quite a reaction to the pneumonia shot--severe fatigue and lethargy such that all I wanted to do was sleep 10-11 hrs. at night, which I did, & rested during the day, I talked with a nurse in Call Center and she was very thorough in asking me questions. I'm over that now, , but it lasted through this past Saturday, (July 8) somewhat (began to taper off by then)." Of  Note: Pt's blood work showed mild iron deficiency anemia. On 06/30, a prescription was sent to pt's local pharmacy for ferrous sulfate 325 MG EC tablet with instructions to take one PO daily with breakfast.
redness and welts at the injection site going all the way down to her elbow; redness and welts at the injection site going all the way down to her elbow; nausea; chills; fever; sweats; could not lift my arms; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweats), HYPOKINESIA (could not lift my arms), VACCINATION SITE URTICARIA (redness and welts at the injection site going all the way down to her elbow), VACCINATION SITE ERYTHEMA (redness and welts at the injection site going all the way down to her elbow) and NAUSEA (nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included METHOTREXATE, FOLIC ACID, LOSARTAN, ESTRADIOL, PANTOPRAZOLE, SIMVASTATIN, LEVOTHYROXINE, TRAMADOL, HYDROXYCHLOROQUINE and VITAMIN B [VITAMIN B NOS] for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), HYPOKINESIA (could not lift my arms), NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever). On 22-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (redness and welts at the injection site going all the way down to her elbow) and VACCINATION SITE ERYTHEMA (redness and welts at the injection site going all the way down to her elbow). On 22-Mar-2021, HYPOKINESIA (could not lift my arms) had resolved. At the time of the report, HYPERHIDROSIS (sweats), VACCINATION SITE URTICARIA (redness and welts at the injection site going all the way down to her elbow), VACCINATION SITE ERYTHEMA (redness and welts at the injection site going all the way down to her elbow), NAUSEA (nausea), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Cancer; Feeling sick; Chronic obstructive pulmonary disease; Asthma; Headache; This spontaneous case was reported by a physician and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant), MALAISE (Feeling sick), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease), ASTHMA (Asthma) and HEADACHE (Headache). At the time of the report, NEOPLASM MALIGNANT (Cancer), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease) and ASTHMA (Asthma) had not resolved and MALAISE (Feeling sick) and HEADACHE (Headache) 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.   Concomitant product use was not provided by the reporter. Treatment information was unknown.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
This spontaneous report as received from the aunt of the consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with dose 1 of a dose of M-M-R II(lot number and dose not reported). On an unknown date the patient experienced red, bumpy rash on her face and tongue became swollen after M-M-R II. The aunt also reported that the patient had a similar reaction to another unspecified vaccine. No treatment information was reported. The outcome of red, bumpy rash on her face and tongue became swollen is unknown. The relatedness for red, bumpy rash on her face and tongue became swollen is unknown for M-M-R II. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple patients of unknown age. The reporter reported that GARDASIL (lot# 1696AA, exp September, 2012) which had been exposed to 31 degrees Fahrenheit for 62 hours were administered to multiple unspecified patients on 20-OCT-2012. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
Painful, swollen lymph node at mid-clavicular line, just above the clavicle.
pregnant patient received VARIVAX; No adverse effects; This spontaneous prospective pregnancy report was received from a registered nurse and refers to a female patient of unknown age.      No pertinent medical history. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On an unknown date the patient became pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) were not reported.  On an unknown date, the pregnant patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. The pregnancy outcome was pending.
unspecified patient received one dose of GARDASIL 9 "2 months ago" and developed the flu on an unspecified date.; This spontaneous report was received from a pharmacist concerning a 26-year-old female patient. The patient's historical conditions, concurrent condition, and drug reactions/ allergies were not reported.  On approximately 07-APR-2019 (reported as 2 months ago), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, number of doses, route of administration, lot number and expiration date were not reported) for prophylaxis.         On an unknown date, the patient developed the flu (influenza).      The outcome and the causality assessment of influenza with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) were not reported.
04APR95 immun given 215PM; 05AP95 afternoon while @ daycare began vomiting, diarrhea, swollen eyes, fever to 101.3; taken to MD rx APAP & DPH; 6APR95 rash all over body w/sl fever lasted until 9APR95;
This spontaneous report as received from a physician via company representative refers to a 15 year old female patient. The patient had no pertinent medical history or current conditions and no drug reactions or allergies. At the moment of this report, patient was not pregnant. On an unspecified date in August 2014, the patient was vaccinated with the first dose of GARDASIL (intramuscular injection, dose 1, 0.5 ml, intramuscularly, batch/lot # and expiration date not reported). There were no concomitant medications. Since an unspecified date in August 2014, after being vaccinated, the patient experienced less energy, more fatigue than normal, some dizziness and some shortness of breath. The patient sought medical attention. The physician reported that he had completed many unspecified blood tests like "mono and thyroid" believing "there was something viral going on"; at the moment of this report some unspecified tests were pending while others "looked good" (exact results, tests and dates were not provided). As treatment for shortness of breath, PROAIR and QVAR were prescribed on an unspecified date in September 2014 (also reported as since last week). The outcome of shortness of breath was reported as recovering/resolving due to the prescribed treatment. The outcome of the other events was reported as not recovered/not resolved. The reporting physician did not provide causality assessment for the events. Additional information has been requested.
On January 24, 2023, I developed a sore throat. I took a rapid COVID-19 test. The result was negative. The next day, the sore throat persisted. I also had chills and aches. I had 99.5-degree temperature which is high for me. I didn't feel well enough to go anywhere. The next day, I went to Urgent Care. The tested me for COVID-19 using a PCR test. The result was positive. I wasn't prescribed anything, but they suggested Coricidin, Tylenol, and Cepacol. I quarantined for the full 10 days. I retested for COVID-19 on February 1, 2023. The result was still positive. I returned to work on Monday, February 6, 2023.
failed to sero-convert; This spontaneous report was received from a physician regarding to a 13 year-old male patient. The patient's medical history and concomitant medications were not reported. Current conditions included the patient has immunodeficiency for unspecified reasons. On an unknown date the patient was vaccinated with 2 doses of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, frequency, route, lot # and expiry date were not reported) for prophylaxis and failed to sero-convert (seroconversion test negative). The physician stated the patient had no additional doses administered. The outcome of seroconversion test negative was unknown. The causality assessment between suspect product and event was not provided.
Pt states around 12/20 she started having intermittent numbness in her legs. By 12/31/2020 she was unable to walk and needed to be carried around. She presented for care on 1/4/2021, and was sent to the ED and stayed in ED for about 1 week where she was diagnosed with Guillain-Barre. She was transferred to Facility for acute rehabilitation on 1/11/2021.
LOW PLATELET COUNT; LIVER ENZYMES HIGH; BODY ACHES; JOINT ACHES; SEVERE NAUSEA; HORRIBLE HEADACHE; This spontaneous report received from a patient (who is a Healthcare professional) concerned a 73 year old, female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A expiry: UNKNOWN) dose was not reported, 1 total, administered to the left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified day, the patient had a horrible headache for 4 weeks and went into the hospital and did bloodwork. She stated that her platelet count went down to 69,000 and liver enzymes were high. She also had a head computerized tomography (CT) scan done as well as went to the eye doctor. Two weeks later the patient went and had another platelet count done and it went up to low normal. She wondered if a month after the vaccine, it was possible to have the side effects. She also stated that she had severe nausea along with the headaches. She also had joint aches as well as body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from low platelet count, and the outcome of liver enzymes high, horrible headache, severe nausea, joint aches and body aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210651622-covid-19 vaccine ad26.cov2.S-Low platelet count. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Patient moved during the second dose. More than half of the vaccine got into the arm but some of the vaccine got into his arm.
tested positive for covid; tested positive for covid; This is a spontaneous report from a Pfizer-sponsored program. A contactable Pharmacist reported similar events for 2 patients. This is a 2nd of two reports. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on 14Dec2020 at single dose for covid-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The reporter was a pharmacist asking if there was a contraindication for administering antibody therapy to a person after they had received the first dose of the covid vaccine. He reported that there was a patient that received the covid vaccine the week of 14Dec and subsequently tested positive for covid on the 23rd and 24th of December. The reporter was trying to determine the safety of administering antibody therapy for the patient even though the patient already got the first vaccine dose.  The reporter reported this question had some urgency and needed the information within 48 hours. The patient underwent lab tests and procedures which included covid test: positive on 23Dec2020, positive on 24Dec2020. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the limited available information, the company considers that a causal relationship between the COVID test positive and vaccination with BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-2020516319 same reporter/ drug/ AE, different patient
I tested positive for Covid-19 on April 13, 2023 my symptoms were coughing, tickle in back of throat, body aches. I was prescribed a cough suppressant, Mucinex, and also Tylenol.
2/21/21  woke  up 2:30am with severe shoulder/neck pain, felt like a broken collar bone, pain intense with a headache.  restless could not sleep.  next day extreme fatigue,  constant coughing, chills, aches and pains unable to work, had to go back to bed every 2 hours for a 2-3 hour sleep.  this same pattern has continued up until today thursday 02/25/21.