chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Nausea/ nauseous; Vomiting; Fever 100.2 Fahrenheit; Dizzy; Dehydrated; Her Arm was sore for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), DEHYDRATION (Dehydrated), VACCINATION SITE PAIN (Her Arm was sore for 2 days), HEADACHE (Headache) and NAUSEA (Nausea/ nauseous) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 206M20A and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Her Arm was sore for 2 days). On 14-Mar-2021, the patient experienced DIZZINESS (Dizzy), DEHYDRATION (Dehydrated), HEADACHE (Headache), NAUSEA (Nausea/ nauseous), VOMITING (Vomiting) and PYREXIA (Fever 100.2 Fahrenheit). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 15-Mar-2021, VACCINATION SITE PAIN (Her Arm was sore for 2 days) had resolved. On 18-Mar-2021, DEHYDRATION (Dehydrated), HEADACHE (Headache), VOMITING (Vomiting) and PYREXIA (Fever 100.2 Fahrenheit) had resolved. At the time of the report, DIZZINESS (Dizzy) and NAUSEA (Nausea/ nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) 100.2 Fahrenheit.         The patient's arm was sore for 2 days and had vomiting x 20 times. On 16-Mar-2021, the patient could hold food in stomach but still felt nauseous and dizzy.   This case was linked to US-MODERNATX, INC.-MOD-2021-051923 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-051923:1st dose
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB (exposed to the following temperatures and cumulative time frames colder than 36F: In September of 2015, the coldest temperature was 34F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34F for 192 hours, for a total of 1,031.3 hours (43 days)) with lot number: L010595, expiry date: 12-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 62-year-old male patient who received RABAVERT (batch number 645011A, expiry date 30th September 2020). On 27th January 2018, the patient received RABAVERT 1 ml. On 27th January 2018, less than a day after receiving RABAVERT, the patient experienced dizziness, cervical spasm, weakness and tightness of jaw muscles. On an unknown date, the patient experienced nonspecific reaction and pharmaceutical product complaint. On an unknown date, the outcome of the dizziness and weakness were unchanged and the outcome of the cervical spasm and tightness of jaw muscles were recovering/resolving and the outcome of the nonspecific reaction and pharmaceutical product complaint were unknown. The reporter considered the dizziness, cervical spasm, weakness, tightness of jaw muscles and nonspecific reaction to be almost certainly related to RABAVERT. Additional details were provided as follows: The patient reported that the RABAVERT vaccine had caused weakness, dizziness, tightness of jaw muscles, and a crick in his neck. The patient was received the RABAVERT as his choice to bring up his titers. He was not at risk in his occupation. The physician which filled QA report stated that the patient reported that he suspected his lot of RABAVERT might be suspect. The patient had experienced adverse drug reactions with this specific unit compared to other injections received. The patient did not have the suspect vaccine but had the lot number. The patient would like to know if this vaccine accidentally had live virus put in it and also wants to know if the production run was faulty. The patient called back inquiring about a lot number from a RABAVERT vaccine and asked if there were any issues reported with the particular lot he provided and the call receiver informed caller that if there were any issues with the vaccine, then there would be a recall, but there had not been a recall for the vaccine. The patient further stated that he has had some reactions to the vaccine, but that he would rather not provide what reactions he has had because they were scary. He was not hospitalized for any of the events. The patient did not provide any additional information.
She developed itchy prominent discrete red plaques on her skin measuring from 2-6 cm in diameter one hour after receiving the flu shot yesterday area she had not taken any other medications.  She had not eaten any new foods or been exposed to any new substances apart from the flu shot.  She also feels like there is involvement in the upper oral mucosa on the hard or soft palate.  These are somewhat tender to touch. Exam by physician 12/9 and 12/16. She is here to follow up with fixed drug reaction following her flu shot.  See last note for details.  There has been a lot of improvement.  The plaques have decreased significantly and discomfort, itching, and discoloration.  She now has plaques about 3-4 cm in diameter but which are faint, with mild hyperpigmentation and no redness.  Rash is resolving much faster and more easily than when she had the initial drug reaction after taking naproxen and Flexeril years ago.  I visualized the plaques on her right wrist and her left axillary area and they appear much better.  I made this a no charge visit because it was just a brief check in on her vaccination reaction and she had no other concerns.  I gave her the government website to report the vaccination reaction if she would like to do this.
Acute kidney failure, unspecified Hypo-osmolality and hyponatremia Hyponatremia
This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy after 2nd shot), DIARRHEA (Diarrhea after 2nd shot), INFLUENZA LIKE ILLNESS (Felt like a bad flu after 2nd shot), ASTHENIA (Weakness of ankles after 2nd shot) and PERIPHERAL COLDNESS (Hands feel cold after 2nd shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for Thyroid disorder. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced DIARRHEA (Diarrhea after 2nd shot), INFLUENZA LIKE ILLNESS (Felt like a bad flu after 2nd shot), NAUSEA (Nausea after 2nd shot), MYALGIA (Body ache after 2nd shot), PYREXIA (Fever 102F after 2nd shot) and CHILLS (Chills after 2nd shot/Severe teeth chattering after 2nd shot). On 02-May-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy after 2nd shot), ASTHENIA (Weakness of ankles after 2nd shot), PERIPHERAL COLDNESS (Hands feel cold after 2nd shot) and FATIGUE (Tired after 2nd shot). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) in April 2021 for Adverse event, at an unspecified dose and frequency. On 30-Apr-2021, DIARRHOEA (Diarrhea after 2nd shot), INFLUENZA LIKE ILLNESS (Felt like a bad flu after 2nd shot), NAUSEA (Nausea after 2nd shot), MYALGIA (Body ache after 2nd shot), PYREXIA (Fever 102F after 2nd shot) and CHILLS (Chills after 2nd shot/Severe teeth chattering after 2nd shot) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy after 2nd shot) had not resolved and ASTHENIA (Weakness of ankles after 2nd shot), PERIPHERAL COLDNESS (Hands feel cold after 2nd shot) and FATIGUE (Tired after 2nd shot) was resolving.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Body temperature: 102 f (High) 102 F. After the second shot on 28-Apr-2021, at 4PM, patient had chills, severe teeth chattering, fever 102F, nausea, diarrhea, body ache, and like a bad flu. Next Morning her boyfriend called MD and gave her Advil. felt better. On Friday she felt better. Four days after shot, a strange sensation down ankles, weakness of ankles, and visited NP. watching it for 1 week, then the tingling moved to upper body. Neuropathy, weird sensation, tingling of legs and hands. When she shake hands and feet, she felt better. Her hands felt cold. She was tired and has GBS like symptoms. As of 14-DEC-2021, she was feeling better but Doctor told her not to get the booster. Diagnosis was made as neuropathy which was still going on. This case was linked to MOD-2021-413148 (Patient Link).
1st dose 3 years ago, has not received 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix 3 years ago).   On an unknown date, the patient did not receive 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: 21-FEB-2023 Reporter's Comment: The pharmacist reported that the patient had no side effects.  However based off of the Centers for disease control and prevention guidance 'to administer as soon as possible' the reporter will be administering it. The reporter did not provided a specific date she will be administering that 2nd dose. The reporter did consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Within 6 hours patient had soreness, hot to touch, and redness. Her Dr. did not think it was infected and did not think there was any tissue damage, just some kind of reaction. The dr. did start antibiotics just in case.
Tingling on face; Dizziness; tongue began to itch and then swell; tongue began to itch and then swell; a hot dark red rash on face to spread to neck and chest; a hot dark red rash on face to spread to neck and chest; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the right arm on 27Jan2021 at 15:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma and type-2 diabetes. The patient was allergic to most antibiotics, latex and adhesive. Concomitant medications included levothyroxine sodium (SYNTHROID) and metformin (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. 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 27Jan2021 at 15:45, the patient experienced tingling on face and dizziness. The patient was told to go home and take Benadryl. On the way home, her tongue began to itch and then swell. She took Benadryl but it did not help and then she had hot dark red rash on her face and it began to spread to the neck and chest. All the while the tongue was still swollen. She took a second Benadryl and by that time the effect of the symptoms started to ease a bit. It was very frightening for the patient. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with two Benadryl tablets. The clinical outcome of the events tingling on face, dizziness, tongue itch and swelling and hot dark red rash on face, neck and chest were resolved on an unknown date in 2021.
--2 reactions to report:  --After the first dose of Pfizer shot, patient experienced shortness of breath immediately after with tight, constricted throat.  An hour later reports having severe chills and fatigue which lasted the next 24-36 hours. This then subsided. --After the second dose, patient reports the same respiratory reaction, but this time also had severe pain in the arm at the injection site, along with heat and redness and itch down the arm.  24 hours later patient reports significant swelling in the right breast (patient was being treated for breast cancer with radiation) went to see dermatologist  and other doctor to have it examined.  They determined that the breast tissue that had radiation is where the reaction occurred.  Doctor described seeing several patients on radiation who had the Pfizer shot report the same side effect.  Patient reports the inflammation in the breast took several weeks to fade away, estimates 4 weeks.  And now still experiences heat and itch in the arm 2.5 months later to this day.
Left thigh, red, swollen after administration of Dtap on 01/31/07.
Developed biopsy-proven urticaria, facial swelling and joint swelling approx 10 days after 3rd injection which occurred 3 weeks after lab-confirmed Covid-19 infection. 3 weeks after start of reaction, has nearly reesolved.
The pt developed a headache, low grade temp and red spots all over body. No treatment was given.
Left thigh red and swollen (baseball size area) patient given Benadryl and monitored for 20 minutes in office.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a low grade fever and cold symptoms, including a cough. Pt sought unspecified medical attention. No further information is available.
Pt felt fine after leaving the clinic after 4-5 hours patient went to the ED felt, fever, tachycardia, chills, myalgia's, developed a painful rash on LUE.
24 hours after vaccination I was extremely fatigued and could not carry on with any athletic or physical activities.
Pt vaccinated with Rubella/DT/Recombivax developed migratory polyarthritis - involving large & small joints.
Accelerated heart rate (and sometimes difficulty breathing) which has continued every day since covid vaccine was received
Case previously recorded as MA2009-4537. Initial case report received from a registered nurse via agency, on 10 NOV 2008. A 60-year-old female patient was vaccinated with an overdose of 1 mL of FLUVIRIN 2009/2010 (batch no. 98468P1) i.m. No adverse effect was reported. Company assessment: Seriousness criterion: not serious. Causality: not applicable. Expectedness assessment according to foreign and local label: Pregnancy is expected and overdose is unexpected regarding vaccination with FLUVIRIN 2009/2010. No change in benefit-risk-ratio. No measures necessary. Agency reference no.: NA09-007809. Follow up report received on 26 Apr 2010: There was an twice attempt to contact reporter, but no response received so far. Therefore the case was closed with a consideration as a lost to follow up.
Headache, muscle pain (extensive), joint pain (extensive), chills and then night sweats. Generalized malaise
eyes feel different; neck stiffness; craving salt; always thirsty; ringing in ears; taste disturbances; diarrhea; Arm sore; hot arm at the injection site; armpit (of the same arm as the injection) hurts; chills; slight fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty) and TINNITUS (ringing in ears) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty), TINNITUS (ringing in ears), TASTE DISORDER (taste disturbances), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE WARMTH (hot arm at the injection site), AXILLARY PAIN (armpit (of the same arm as the injection) hurts), CHILLS (chills), PYREXIA (slight fever) and HEADACHE (headache). At the time of the report, OCULAR DISCOMFORT (eyes feel different), MUSCULOSKELETAL STIFFNESS (neck stiffness), SALT CRAVING (craving salt), THIRST (always thirsty), TINNITUS (ringing in ears), TASTE DISORDER (taste disturbances), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE WARMTH (hot arm at the injection site), AXILLARY PAIN (armpit (of the same arm as the injection) hurts), CHILLS (chills), PYREXIA (slight fever) and HEADACHE (headache) had not resolved.            Concomitant medication included Anxiety medication for unspecified indication. Treatment medication included Tylenol to alleviate symptoms. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-091871 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-091871:First dose
pt recv vax 21MAY98 & 1 day later pt devel a local rxn w/swelling, redness, 3 inch induration, which wahsot to touch;
Child was Administered TD, IPV, MMRI Hep B at around 12:05 pm was giving mom instructions for care of child after immunization. Tylenol for fever cool cloths etc. When child became unresponsive and with convulsive seizure activity. Baby was listless and convulsing eyes rolled back and breathing was labored through pursed lips. Seizure activity lasted 2-3 minutes child was groggy and sleepy when child finally came around. Child was transported to ER per ambulance as per mom's request
Transplant patient received half dose for 3rd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Transplant patient received half dose for 3rd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Transplant. Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Transplant patient received half dose for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Transplant patient received half dose for 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.
2-5-07 TC from patient approx 1130 AM to report on Sat 2-23-07 rash on entire back and neck and couple in head. Red itching, no fever or pain. Said received immuz here 1-22-07. Told probable reaction to one of immunizations or possibly 2. Told to go to ER or MD if fever - Received Caladryl for itching.
Soreness L upper extremity cellulitis some redness, swelling subjective fever and chills.  03/02/2007 MR received from treating facility for an ER admission for c/o fever, redness and swelling in his Left arm following Flu and Pneumococcal vax.  Initially seen in the ER and sent home on PO antibiotics, he returned the following day with increased redness and swelling and was admitted for IV antibiotics. PE:  WNL except for swelling and redness in the left triceps area, extending distally to the mid forearm. Discharge DX:  Left upper extremity cellulitis.  Hypertension , controlled, Stable CAD, Diabetes mellitus type 2, Hyperbilirubinemia, question Gilbert's syndrome.
Pt received flu vaccine at pharmacy on 10 11 19. Pt immediately reported pain during and after vaccination. Pt stated pain was unusual for a vaccine. Rph instructed to use cool compress and otc acetaminophen and to follow up with pharmacy if pain last more than a few days or is unusually painful. Pt presented to pharmacy 11-1-19 reporting continued pain. Pt reported had talked to Rph about pain and about Rph's suggestions to help. Pt stated pain persists. Pt stated pain was "at least an 8 out of a pain scale of 10" for a few or several days after the vaccination. Pt stated pain had gradually improved, but pt was still experiencing pain. Pt described current pain as "aching feeling" (but not too painful), but stated pain was worse when she tried to do activities with the arm and put pressure on arm. Pt states the painful area was in the injection arm (left arm) from the injection site down towards the elbow. Pt has not received treatment or made appt with primary care provider. Pt is considering this option.
Breakthrough case of COVID-19.; Breakthrough case of COVID-19.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single 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), SUSPECTED COVID-19 (medically significant) all with onset 26Jan2022, outcome "unknown" and all described as "Breakthrough case of COVID-19.". It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of ROTATEQ (Lot# 670011/1393AA, expired date 03-DEC-2012) (dose and route not reported). No adverse effects were reported. It was not known if the patient sought for medical attention. Additional information has been requested.
Patient complained of arm tenderness and pain from the first day of shot until she came back for the second vaccine.