chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) at the age of 8 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination : Yes. The patient's concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 1), for COVID-19 immunization, reaction(s): "Prior to vaccination, was the patient diagnosed with COVID-19?: Yes", "Prior to vaccination, was the patient diagnosed with COVID-19?: Yes". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Dec2021, outcome "recovered" (Dec2021), described as "sore arm"; HEADACHE (non-serious) with onset 11Dec2021, outcome "recovered" (Dec2021), described as "headache"; FATIGUE (non-serious) with onset 11Dec2021, outcome "recovered" (Dec2021), described as "fatigue". Therapeutic measures were not taken as a result of pain in extremity, headache, fatigue.  Additional information: It was unknown if the patient was received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A pharmacist reported that an 18 year old female experienced nausea, left-sided numbness and dizziness coincident with RabAvert post-exposure vaccine therapy. The pt was reported to have an allergy to shellfish. The pt was exposed to a bat in a cabin while camping. The pt received her 5th post-exposure RabAvert injection (all doses were reportedly given on time) in the left deltoid on 8/16/01. She experienced nausea, weakness, left-sided numbness, dizziness and was hyperventilating. There was no local reaction at the injection site. On 8/17/01, a physician in an ER dx'd her as having "hyperventilation syndrome" and possible "mild serum sickness" and felt that the pt had probable "viral syndrome". The pt also experienced numbness to her fingertips, nausea, dizziness and questionable consciousness. The pt was treated with Vistaril 50mg, IM, in the ER. As of 8/29/01, it is unknown whether the pt received any further injections of RabAvert or whether the events resolved.
numbness in left hand, middle, index finger, thumb, and ring finger; pain along inner arm; This is a spontaneous report from a contactable physician (who is also the patient). A 78-years-old male patient received bnt162b2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left, left deltoid on 21Jan2021 6:30pm (Batch/Lot Number: EL9267) as 1ST DOSE, SINGLE for covid-19 immunisation (preventative). Patient Age at Time of Vaccination in Months: or Years: 78 years. Medical history included diabetes mellitus, coronary artery disease, high blood pressure, prostate cancer and a little arthritis. Concomitant medication(s) included metformin (METFORMIN), metformin hydrochloride, sitagliptin (JANUMET), ramipril (RAMIPRIL), amlodipine (AMLODIPINE), atorvastatin (ATORVASTATIN), metoprolol (METOPROLOL) and aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced pain along inner arm on 03Feb2021 and numbness in left hand, middle, index finger, thumb, and ring finger on 04Feb2021. He developed pain in the arm, not at the injection site, but along the inner arm. The next day he developed numbness in the left side of the hand, in the middle and ring finger. A couple of days later he developed teh same thing on the thumb and index finger. A few days later, he woke up in the night and had wrist drop in the left hand. He recovered most strength of muscles and was able to lift the fingers. Within the next few days, he recovered his strength in his muscles. The numbness continued to be there but, slowly showing some improvement. He still has little patches of it. The outcome of the event pain in extremity was unknown and hypoaesthesia was recovering. Communication: The caller was provided with phone number of , option 3, for COVID-19 vaccine inquiries.
whole body nerve pain; chills; This is a spontaneous report from a non-contactable consumer (other non-HCP).   A 46-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on 31Aug2021, as a single dose for COVID-19 immunization. Medical history included diabetes and neuropathy pain. Concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced whole body nerve pain and chills. Caller reported that she received the second dose of the Pfizer covid vaccine yesterday 31Aug and has been experiencing severe whole body nerve pain and chills. caller has Diabetes and has neuropathy pain but after the vaccine her whole body was hurting and she has never experienced it before. Caller wanted to know about severe never pain reported with diabetes. The clinical outcome of the events was unknown. No follow up attempts are possible; information about lot/batch number cannot be obtained.   No further information is expected.
Soreness on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Gout. Concomitant products included DIAZEPAM (VALIUM) for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness on injection site). At the time of the report, VACCINATION SITE PAIN (Soreness on injection site) had resolved.            The patient with preexisting medical conditions on 24-Feb-2021 received their second dose and reported of having experienced soreness on the injection site similar symptoms, with same onset and remission that they experienced post receiving their first dose of vaccine. The patient had their first dose of Moderna COVID-19 vaccine on 27-Jan-2021 and experienced soreness on the injection site on the following day, which resolved in the span of approximately one day.  Concomitant medications reported by the patient also included gout medication and muscle relaxants. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-064955 (Patient Link).
within a few hours I got headache, body aches, fever ,stomach upset. By the 23rd I started having blurry vision and redness with a burning sensation in my eye's , I have been getting flu shots every year since 2008 and have never had these effects or anything close to these effects.
Itchy skin; Patchy skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy skin) and SKIN DISCOMFORT (Patchy skin) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis, Anxiety, Depression and Bladder discomfort.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy skin) and SKIN DISCOMFORT (Patchy skin). At the time of the report, PRURITUS (Itchy skin) and SKIN DISCOMFORT (Patchy skin) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's concurrent condition also included bladder control issues.  No concomitant and treatment medication details were reported.
Couldn't get warm; Chills/shaking; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Couldn't get warm), CHILLS (Chills/shaking) and MYALGIA (Body Aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced FEELING COLD (Couldn't get warm), CHILLS (Chills/shaking) and MYALGIA (Body Aches). At the time of the report, FEELING COLD (Couldn't get warm), CHILLS (Chills/shaking) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-068226, MOD-2021-068239 (Patient Link).
Maybe she had COVID; Maybe she had COVID; Tiredness; chills; arm hurts; headaches; feeling funky; It is almost like a light fever that she has; is not feeling too great after the booster; is not feeling too great after the booster; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).  A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on an unspecified date as DOSE 3 (BOOSTER), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was receiving booster dose and began experiencing tiredness, chills and arm hurts. Patient was not feeling too well after the booster.  She did fine after the other 2.  Maybe she had COVID.  She has been really tired, and was having chills, headaches, nothing serious, and was feeling funky.  It was almost like a light fever that she had.  Her arm still hurts.  It had been since Friday. She would like to know if what she was feeling is typical and how long will it continue.  She has heard from her pharmacist and she just sort of passed her off and said it could be 5 days, but she said that some people have had a sore arm for weeks.  She did not have any specific information on anyone to report that had a sore arm for weeks. The outcomes of events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came into office for a CPE. Her MICR stated she was due for a Men B vaccine. Provider ordered a Men B vaccine. Staff prepared and administered a Men Conjugate (menvo). This vaccine was verified by Staff to be menvo but was not verified to the patient need. Staff realized this error when documenting the vaccine in the EMR.
The pt developed redness and warmth at the injection site by the same evening of injection. By the next day, she developed hives around the injection site at right deltoid. 6 days post vax, all are resolving except for roughness of skin around site. No treatment was given.
Depression - does not want to get out of bed, has been crying frequently, feelings of worthlessness. All very unlike his normal self Migraines: severe light sensitivity, noise sensitivity, touch sensitivity, nausea.
2nd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-Apr-2022 Reporter's Comments: Did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix yet, which led to incomplete course of vaccination.
Pain in arm; Head ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Head ache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Migraine (headache). Concomitant products included SULFASALAZINE, INFLIXIMAB (INFLECTRA [INFLIXIMAB]) and METHOTREXATE SODIUM for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Head ache). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Head ache) outcome was unknown.            No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-043299 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-043299:Case for first dose
not feeling well; Fever; Fatigue; Muscle pain; Joint pain; Chills; Injection site pain; A spontaneous report was received from an HCP concerning a female patient who experienced not feeling well, fever, fatigue, muscle pain, joint pain, chills, and injection site pain.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On 29 DEC 2020, the patient received their first of two planned doses of mRNA-1273 (LOT/BATCH# Not Provided) for prophylaxis of COVID-19 infection.   On 29 DEC 2020, after receiving the COVID-19 vaccine, the patient experienced fever, fatigue, muscle pain, join pain, chills, injection site pain, and was not feeling well. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The event not feeling well was considered not resolved on 30 DEC 2020.   The outcomes for the events fever, fatigue, muscle pain, joint pain, chills, and injection site pain were not provided.   The reporter did not provide an assessment for the events not feeling well, fever, fatigue, muscle pain, joint pain, chills, and injection site pain.; Reporter's Comments: This case concerns a female patient of unknown age. The patient's medical history was not reported. The patient experienced expected events of pyrexia, fatigue, myalgia, arthralgia, chills and injection site pain and unexpected event of feeling abnormal. The events occurred the day the first dose of mRNA-1273 was administered. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pain in the left side of my body from my lower back to my feet. I feel like I was hit by a car or fell down.  Left Arm pain in the place of injection is normal.  Fatigue on the day of vaccination and 2 days after. It is getting better by time. I forced myself to do some light activity and walk around. I felt better.
6pm onset of full body chills, followed by 103 fever and extreme sweating. Migraine headache all night, extremely rapid heart rate and faint feeling for several hours, followed by cough and intermittent taste of bile in mouth.
Information has been received from a 85 year old female patient, with codeine and sulfonamide allergy, who on 15-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 16-DEC-2008 the patient experienced injection site reaction, redness, swelling and pain. The patient did not seek medial attention. the patient's injection site reaction, redness, swelling and pain persisted. Additional information is not expected.
I was feeling pretty rotten, so I took my temperature, and I had a fever. I took a home COVID-19 test, and it was positive. I called the doctor and he prescribed PAXLOVID. I started the dose of medication on the same day. Within 2 hours I was feeling better. I felt well for about a week and then I started to feel bad again. I was achy feverish and tired. I retested myself and I had a rebound case of COVID-19. No additional treatment has been requested to address the rebound case. I felt better within 2 or 3 days. I continue to cough, and I still have ongoing fatigue. Both have been ongoing since the initial case. I am not able to shake the cough and fatigue.
Vaccine given on 7/24/18 - redness noticed that night. Increased redness during the day 7-25-18 and went to ER. Placed on KEFLEX.
This spontaneous report as received from a certified assistant/healthcare worker refers to multiple patients of unknown demographics. On 27-JUL-2015, 28-JUL-2015, 29-JUL-2015, 30-JUL-2015, 31-JUL-2015, 03-AUG-2015, 05-AUG-2015, 06-AUG-2015, 07-AUG-2015, 12-AUG-2015, 25-AUG-2015, 04-SEP-2015, 10-SEP-2015, 14-SEP-2015, 17-SEP-2015 and 21-SEP-2015, the patients were vaccinated with doses of improperly stored GARDASIL (Lot # K011325, expiry date: 08-APR-2017). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA After receiving the vaccine developed symptoms later that evening, fatigue, muscle aches (nighttime only) and headache that was relieved with Tylenol .
Injection Site reactions are getting worst; itching on the Injection Site; Injection Site looks like Bee-Sting; Swollen Injection Site; Red Injection Site 2; A little Sore Throat; More sore at the injection site; Little Soreness at the Injection Site; Redness at the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Little Soreness at the Injection Site), ERYTHEMA (Redness at the Injection Site), INJECTION SITE REACTION (Injection Site reactions are getting worst), INJECTION SITE PRURITUS (itching on the Injection Site) and INJECTION SITE REACTION (Injection Site looks like Bee-Sting) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ARTHRALGIA (Little Soreness at the Injection Site) and ERYTHEMA (Redness at the Injection Site). On 29-Jan-2021, the patient experienced INJECTION SITE REACTION (Injection Site reactions are getting worst), INJECTION SITE PRURITUS (itching on the Injection Site), INJECTION SITE REACTION (Injection Site looks like Bee-Sting), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE ERYTHEMA (Red Injection Site 2), OROPHARYNGEAL PAIN (A little Sore Throat) and INJECTION SITE PAIN (More sore at the injection site). On 23-Jan-2021, ARTHRALGIA (Little Soreness at the Injection Site) and ERYTHEMA (Redness at the Injection Site) had resolved. At the time of the report, INJECTION SITE REACTION (Injection Site reactions are getting worst), INJECTION SITE PRURITUS (itching on the Injection Site), INJECTION SITE REACTION (Injection Site looks like Bee-Sting), INJECTION SITE SWELLING (Swollen Injection Site), INJECTION SITE ERYTHEMA (Red Injection Site 2), OROPHARYNGEAL PAIN (A little Sore Throat) and INJECTION SITE PAIN (More sore at the injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Narrative: COVID infection following COVID vaccine series 02/23, Pfizer, dose #1 03/22, Pfizer, dose #2 09/01 COVID swab, result: detected 09/01 pt cc: chills, cough, fatigue, fever, myalgias, sore throat exposure: unknown 09/01 SARS-COV-2 Variant Sequencing result: pending
None so far. Patient stated that she had not received any Covid vaccines so she got full Moderna dose. We found out when recording in VIIS that she dad received J&J on 03/06/2021. So she received full dose of Moderna  instead of half dose.
This spontaneous report as received from a other via GSK (MRF#492166-1024460209) refers to a female patient of unknown age. On 21-APR-2014 the patient was vaccinated with dose 1 of RECOMBIVAX HB (lot# was not reported). The patient had a severe latex allergy and angioedema response to the first dose of RECOMBIVAX HB that she received and would therefore be completing her last two parts of the series with ENGERIX-B. She was scheduled to receive her first dose of ENGERIX-B on 22-MAY-2014. The outcome of latex allergy, interchange of vaccines and angioedema was unknown. Additional information has been requested.
RED, HOT AND ITCHY RASH THAT STARTED ON THE LEFT ARM MOVING TO THE RIGHT ARM, STOMACH, BACK AND THIGHS. THE RASH IS WORSE ON THE LEFT ARM. PATIENT HAS BEEN TAKING BENADRYL AND APPLYING CALAMINE LOTION AND CORTISONE CREAM. I RECOMMENDED SHE GO TO THE DOCTORS OFFICE HOPING THEY RECOMMEND STEROIDS TO STOP THE SPREAD.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19".  Clinical course: It was reported that patient and his family developed COVID-19. Uncertain of their vaccination status.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Knot in the arm of the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot in the arm of the vaccination) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Knot in the arm of the vaccination). At the time of the report, VACCINATION SITE MASS (Knot in the arm of the vaccination) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The reporter got the booster on 13-Dec-2021 and at the time of the call, on 15-Dec-2021 the patient was still feeling a knot on their right arm where the dose was administered.