chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in the arm , both arms; Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees; Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.; Skin hurt; Cold burn; Shivery feeling from the shoulder all the way to the elbow of both arms/shivery feeling from the hip down and is getting close to the knees/ shivering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm , both arms), BURNING SENSATION (Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees), PERIPHERAL COLDNESS (Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.), PAIN OF SKIN (Skin hurt) and COLD BURN (Cold burn) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 vaccination: J and J COVID-19 Vaccine on 30-Mar-2021. Past adverse reactions to the above products included No adverse event with J and J COVID-19 Vaccine. Concomitant products included VITAMINS NOS for an unknown indication.    On 17-Nov-2021 at 5:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm , both arms), BURNING SENSATION (Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees), PERIPHERAL COLDNESS (Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.), PAIN OF SKIN (Skin hurt), COLD BURN (Cold burn) and CHILLS (Shivery feeling from the shoulder all the way to the elbow of both arms/shivery feeling from the hip down and is getting close to the knees/ shivering). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 18-Nov-2021 for Adverse event, at a dose of At morning. At the time of the report, PAIN IN EXTREMITY (Pain in the arm , both arms), BURNING SENSATION (Burning sensation from the shoulder all the way to the elbow of both arms/a burning sensation from the hip down and is getting close to the knees), PERIPHERAL COLDNESS (Cold sensation from the shoulder all the way to the elbow of both arms/a cold sensation from the hip down and is getting close to the knees.), PAIN OF SKIN (Skin hurt), COLD BURN (Cold burn) and CHILLS (Shivery feeling from the shoulder all the way to the elbow of both arms/shivery feeling from the hip down and is getting close to the knees/ shivering) outcome was unknown.
Patient tested positive for natural antibodies on July 6 2020 and again October 6, 2021.  Received Janssen vaccine on October 8 2021. Received ?full dose? of Moderna on 1/19/22. at 4:15 pm. Woke up at 3:15 am with chills, achiness and fainted at 3:15 am Jan 20, 2022. Experienced High fever over 101.7 with Tylenol every 4 hours for 36 hours after vaccine.
Became red and hot to touch. Started on KEFLEX 500 mg BID x 7 days.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax on 1nov94;no sxs noted;felt feverish for rest of wk;6nov94 felt real bad;while on phone 7nov94 at 6:30pm passed out;to er; p/CT scan & EEG still unconscious;to hosp from 8nov94 to 11nov94;tentative dx viral meningitis;
Not received the 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose yet) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included DULAGLUTIDE (TRULICITY), INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (LANTUS), OMEPRAZOLE, SERTRALINE HYDROCHLORIDE (ZOLOFT), LISINOPRIL and ATORVASTATIN for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not received the 2nd dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment medications were reported
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 77-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: 2692147) for covid-19 immunisation. The patient's relevant medical history included: "stage 3 COPD" (ongoing), notes: Reporter said he is a husband and has a wife in ICU now due to complications. The patient's 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: she tested positive for Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The reporter (patient's husband) stated that his wife (patient) in ICU now due to complications of her stage 3 COPD and she tested positive for Covid-19. A 74 year old husband stated his wife is 3 years older than him and she is on 3 liters of oxygen all the time and her medications. The reporter stated wife has received Pfizer Covid-19 vaccines.  Follow-up attempts are completed. No further information is expected.
Pain at injection site prevented sleep. Fever began on day 2 from 99.4-102.5 for nearly 20 hours. Day 3 sever fatigue and nausea requiring going into work several hours late.
DTAP + IPV given on 06/01/2020 @ 11am, fever spike next day, welt on lower right corner under mouth, 2 days after injection, a small light colored rash appeared . Injection given on the right leg. Called doctor, facetimed as well, said it was normal, give Benadryl 5ml, and if it got worse to call back.  MMR-V given on 06/10/2020 @ 11am, swelling and a welt immediately after. Swelling started to go down a little, then on 06/12/2020 burn looking type rash appeared and had spread. Welt never went away. Contacted doctor, they said it was normal and to do a cold compress, and if it got worse to call back. Injection give on left leg.
Patient was given incorrect vaccine. Patient was given 0.5mL IM of monovalent vaccine instead of correct bivalent vaccine booster for Moderna. Stated side effects of tiredness and fatigue.
Youth was vaccinated covid-19 first dose on date 8/30/2021, covid-19 second dose on date 9/23/2021, covid-19 booster on date 10/14/2021. no adverse reaction
The next day after getting the vaccine around 7:30am i started having sever cramping and sweating and by noon I started having rectal bleeding which continued through the evening into the next day
Left arm cellulitis. Prescribed rocephin 1 mg, reflex 50 mg
1) Loud tinnitus in both ears beginning one week after vaccination, persisting 2) Right-sided headache occurring behind/around eye, beginning one week after vaccination, persisting 3) Blurred vision in right eye, beginning two days after vaccination, persisting
This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (knee unstable), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and NAUSEA (nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B2117) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced FATIGUE (fatigue). On 15-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (knee unstable), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, MUSCULOSKELETAL DISCOMFORT (knee unstable), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain), NAUSEA (nausea) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported  No treatment information were  reported  It was reported that Patient consulted HCP on 18 march 2021     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Event outcome was updated as recovered/resolved.
Patient had swelling of the eye's, lip's and ear's. Also had an episode of vomiting. some difficulty breathing.Patient was given vaccines and had left the clinic for about 30 min. at which point she started to react. Patient was rushed back to out clinic where she was given Benadryl and supervised for 30mins. at this point she seamed to be acting normal with still some swelling so Dr. sent her home. Mom to call with any other issues within a 24hr period. no swelling at any of the injection sites were noted.
Shivers; Low Grade Fever; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Shivers), PYREXIA (Low Grade Fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced CHILLS (Shivers), PYREXIA (Low Grade Fever), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Feb-2021, CHILLS (Shivers), PYREXIA (Low Grade Fever) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no corrective treatment was received
Patient received Tdap and meningococcal vaccines and developed a frontal headache about 5 minutes after administration. She was observed for 20 minutes; no other reactions.
Red, hot, swollen and painful arm. Went to Hospital and was admitted for 3 days with cellulitis. On 3 or 4 different antibiotics.
R upper arm pain, swelling, firmness, warmth, difficulty moving the arm due to pain.
No additional AE reported; a GARDASIL 9 was administered off label to a 48 year old woman within the last few days. The physician insisted the patient receive the vaccine due to DNA testing that confirmed a diagnosis of cervical HR HPV.; the patient receive the vaccine due to DNA testing that confirmed a diagnosis of cervical HR HPV.; This spontaneous report was received from a pharmacist, referring to a 48-year-old female patient. The patient's pertinent medical history, concomitant medications, previous drug reactions, or allergies were not reported. The patient's concurrent conditions included cervical HR HPV (Papilloma viral infection).  On an unspecified date in 2021, the patient was vaccinated off label with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (ml) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis. The physician insisted the patient receive the vaccine due to deoxyribonucleic acid (DNA) testing that confirmed a diagnosis of cervical high-risk human papillomavirus infection (HR HPV) (product use in unapproved indication). No additional adverse event (AE) reported.
Pt. received immunization on 6/17, 2:51 pm, in both (L) and (R) thigh. 6/18 Pt. brought in for recheck - swelling left thigh, no fevere or chills. 6/19 Pt. returned for recheck. Swelling both thighs. 6/21/13 Pts mother states child improving.
Felt very sleepy, wanted to sleep all day; Flu like symptoms; Headache for 24 hours; felt chills; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Felt very sleepy, wanted to sleep all day), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache for 24 hours) and CHILLS (felt chills) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 011A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, PIOGLITAZONE, INSULIN LISPRO (HUMALOG), FENOFIBRATE, ATORVASTATIN and LISINOPRIL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Felt very sleepy, wanted to sleep all day), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache for 24 hours) and CHILLS (felt chills). At the time of the report, SOMNOLENCE (Felt very sleepy, wanted to sleep all day) and HEADACHE (Headache for 24 hours) had resolved and INFLUENZA LIKE ILLNESS (Flu like symptoms) and CHILLS (felt chills) outcome was unknown.            No concomitant medication information was provided.  No treatment medication were provided.
Employee c/o 4-5 pain to right deltoid. Hand feels "Heavy, tingling  Right hand strength decreased. " B/P 124/81 P 70 R 16 POX 99% on room air Temp. 98.9. First noted symptoms on 09/25/2020.
This spontaneous report was received from the patient's husband referring to his wife of unknown age. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated, in a pharmacy, with a dose of ZOSTAVAX subcutaneous for (lot number and expiration date were not provided). No concomitant therapies were reported. According to the reporter, 48 hours following vaccination, the patient developed injection site pain, injection site swelling and injection site erythema. The outcome of this events was unknown at the time of this report. The reporter did not provide a causality assessment between the event and therapy with ZOSTAVAX. Additional information is not expected, since there is no contact information to follow up.
left side chest pain, warm feeling on the inside, dizziness, feeling that she couldn't stand up without getting lightheaded, nausea.    Gave patient a bottle of water and a chocolate bar.     Sent to ED     FROM ED NOTE:  She states about 10 minutes after the injection she felt a warm feeling. A bit of nausea. She had a little chest tightness.   She describes this as similar to IV contrast studies. This is resolving. She denies trouble breathing. Did have a little chest tightness on this persist. On the monitor patient has pulse ox of 100%. Respiratory rate of 18.
Information has been received a Registered Nurse for the pregnancy registry for GARDASIL, concerning a 19 year old female patient with no known allergies and no pertinent medical history, who on 19-JAN-2009 was vaccinated intramuscularly with 0.5 ml of her first and only dose of GARDASIL (Lot# 660391/0063X) while she was pregnant. The urine pregnancy test was positive (LMP: 12-DEC-2008, EED: 18-SEP-2009). As of 15-JAN-2009 the patient was fine. In follow-up the registered nurse reported that they were unable to obtain authorization from the patient. Follow-up information from another registered nurse revealed that the patient has a medical history of Chlamydia infections in September 2007 and January 2009. In February 2009, the patient experienced an elective termination of pregnancy. It was unknown if the fetus was normal or if the products of conception were examined. The patient was seen for LPE (during early-pregnancy) pregnancy test which was positive. The patient did not have obstetric care due to pregnancy terminated per the patient. Upon internal review, elective termination was considered to be an other important medical event. Additional information is not expected.
Redness / in the injection side; Painful in the injection side; Headache; Fever; Painful on the right side of patient face; Still with some discomfort on your face; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020, the patient received the 1st dose of Shingrix. On 25th December 2020, 7 days after receiving Shingrix, the patient experienced injection site erythema, injection site pain, headache, fever, facial pain and facial discomfort. On an unknown date, the outcome of the injection site erythema, injection site pain, headache, fever and facial pain were unknown and the outcome of the facial discomfort was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, headache, fever, facial pain and facial discomfort to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported bit could be 66 or 67 years. The patient was not immunocompromised.  No information about lot number as it was given in a pharmacy and not in doctor´s office.  The patient went to Emergency room but there was no diagnosis.  The patient still had some discomfort on her face at the time of reporting. The reporter consented to follow up.
pt recvd vax; pt felt warm on 22jun94; pt hit head on tile floor at restaurant 2:30pm; pt had seizure & taken to hosp;
Night sweats beginning at unknown time, noticed upon waking at 6:00 AM. Heart rate about 20 points higher than normal throughout course of sleep as evidenced by Apple Watch data.
PM - severe headache/pressure, chills, body aches. Fever spiked 101.6 next day severe head pressure, chills/body ache fever. Went to drs - fever 101.6 - Lt arm raised and redness developed - slight itch - bright red - (took pictures). Headaches continued - fever subsided along w/chills & aches after - 4 days - mostly severe head pressure & pain for 4 days. 1st time for Pneumonia shot & whooping cough. Tetanus injection was already given within the last 10 yrs.
Immunizations were not entered  in the entirety at time of administration of vaccinations thus child inadvertently received unnecessary dose of IPV. No reaction or adverse effect from child , guardian aware of need to repeat dose at later interval
severe dehydration; can't sleep; going to the bathroom so frequently; Getting upset; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received first dose of (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN8733 and expiry date was not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0161 and expiry date was not reported), via an unspecified route of administration, on an unspecified date in Apr2021, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included Severe anxiety from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced severe dehydration, she could not sleep, was going to the bathroom so frequently and she got upset. Outcome of the events was unknown.  Follow-Up (22Oct2021): Follow-up attempts are completed. No further information is expected.
Hives initially in the area of the injection- then became red and very itchy, somewhat raised- about 2 inches by 4 inches
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 9:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.02.  Concomitant products were not provided.  On 15-Apr-2021, at excursion time 9 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021. On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4PM: 42 and 5 PM; 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
My tuberculosis vaccine scar became red, swollen and tender to the touch. It lasted 3 days and then went back to normal.   I have also been experiencing headaches since 3 days after the first dose.