chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had redness all the way down to elbow for a week; indurated area in injection site.; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (She had redness all the way down to elbow for a week) and VACCINATION SITE INDURATION (indurated area in injection site.) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062S22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st Booster,lot# 09312A) on 15-Jul-2022, Moderna COVID-19 Vaccine (2nd Primary series, 09312A), Moderna COVID-19 Vaccine (1st Primary series and  002A21A). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    In February 2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, the patient experienced ERYTHEMA (She had redness all the way down to elbow for a week) and VACCINATION SITE INDURATION (indurated area in injection site.). In February 2023, ERYTHEMA (She had redness all the way down to elbow for a week) had resolved. At the time of the report, VACCINATION SITE INDURATION (indurated area in injection site.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. Patient received Moderna Covid 19 Bivalent 2 weeks ago. No treatment medications was provided.   This case was linked to MOD-2023-712635 (Patient Link).
Patient throwing-up since 3 am. She stated she is dizzy; head, stomach and left eye hurts. Temp: 99.9 degrees.
69 y/o female patiet, AAOx3, presents with sudden dizziness, diaphoresis, generalized headache, and subjective hyperthermia 15 minutes after administration.
Patient developed localized reaction to left thigh that radiated towards left inner thigh (red, macular, papular rash).  No pain or itchiness reported.  No other symptoms were reported.  Patient had also developed fevers that ranged between 101-103.6, which was relieved by Tylenol and Motrin.
had systemic flu-like symptoms with no fever; arm began to swell 10 days after the vaccine; swelling covered my arm and was one inch from elbow; she noticed a red circle that grew bigger during the night; felt crappy for a day; arm hurt for "like a week after the injection"; arm was very painful; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm began to swell 10 days after the vaccine; swelling covered my arm and was one inch from elbow), MALAISE (felt crappy for a day), INFLUENZA LIKE ILLNESS (had systemic flu-like symptoms with no fever), PAIN IN EXTREMITY (arm hurt for "like a week after the injection"; arm was very painful) and RASH ERYTHEMATOUS (she noticed a red circle that grew bigger during the night) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurt for "like a week after the injection"; arm was very painful). On 15-Jan-2021, the patient experienced MALAISE (felt crappy for a day). On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm began to swell 10 days after the vaccine; swelling covered my arm and was one inch from elbow) and RASH ERYTHEMATOUS (she noticed a red circle that grew bigger during the night). On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (had systemic flu-like symptoms with no fever). On 15-Jan-2021, MALAISE (felt crappy for a day) had resolved. On 28-Jan-2021, INFLUENZA LIKE ILLNESS (had systemic flu-like symptoms with no fever) had resolved. At the time of the report, PERIPHERAL SWELLING (arm began to swell 10 days after the vaccine; swelling covered my arm and was one inch from elbow) and RASH ERYTHEMATOUS (she noticed a red circle that grew bigger during the night) was resolving and PAIN IN EXTREMITY (arm hurt for "like a week after the injection"; arm was very painful) had not 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.   No concomitant medications were reported.  On 25JAN2021, the patient sought medical advise from her HCP about the a red circle that grew bigger during the night." She reported that her doctor instructed her to elevate her arm with ice and take ibuprofen.  The caller stated that the 27JAN2021 and 28JAN2021 were the worst days. On 28JAN2021, the patient emailed her doctor and was prescribed antibiotics. The patient reported that she did not take them; she used a steroid cream instead and the next day her arm started to feel better. The patient also reports taking diphenhydramine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-DEC-2015 at 13:05, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.4 and 5.0 (units unspecified) respectively. 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.
No adverse event reported; Patient was administered an improperly stored PROQUAD; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's past relevant drugs, medical history, or concurrent conditions was not provided. Concomitant therapies included sterile diluent.   On 30-OCT-2019, the patient was vaccinated with improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number: S012472 which was verified to be a valid lot number; expiration date: 20-OCT-2020) as prophylaxis (dose, dose number, route of administration, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion between 15 to 46 degrees Fahrenheit (F) (36 degrees F) for 336 hours. There was no previous temperature excursion. No adverse event was reported.
Nausea, Dizziness, flushed feeling. Person suffers from panic attacks, low BP 92/58.
fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial tingling/bilateral hand and foot tingling; double vision; disorientation; joint pain; orthostatic hypotension; chills; photophobic/photophobia; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left deltoid on 26Jan2021 15:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The first dose was received on 05Jan2021 15:00 (lot number: EL1284) on the left arm. Medical history included herpes simplex virus (HSV), Superior Oblique Myokymia, and Lyme Disease; from an unspecified date and unknown if ongoing. Patient was not pregnant. Concomitant medications included calcium citrate, magnesium citrate (CAL/MAG CITRATE), ergocalciferol (VIT D), fish oil (OMEGA 3), and paracetamol (TYLENOL). The patient previously took VICODIN and flu vaccine as a child, and experienced allergies. The patient experienced headache, nausea, dizziness, facial tingling, double vision, disorientation, joint pain, orthostatic hypotension, chills, photophobic from 27Jan2021 05:00. On 02Feb2021, she experienced dizziness, headache, nausea, photophobia, facial tingling, bilateral hand and foot tingling, GFR 47 all other CBC, cmp normal. There was headache, nausea, photophobia, facial tingling on 07Feb2021 and on 10Feb2021, tingling and fatigue from waist to feet posteriorly and bilaterally. She had lab test drawn and blood work done when she was sick and her GFR came back as 47, so everything else was normal, and her GFR was 47 which was out of range. On 03Feb2021 was the first test and it was 2 weeks that she had to repeat test just to make sure it was back in normal range which it was. Thee patient was still experiencing the events but 'not as bad', and stated she can still function. Her side effects were improving but she still have a daily headache and paresthesia. The events resulted in physician/ healthcare professional visit. Patient was recovering from the events. ZOFRAN was given as treatment for the events. Patient stated she takes Tylenol but her doctor want her not to take medication for a while but she had to take Tylenol. Patient had no covid prior to vaccination and has been tested (nasal swab) post vaccination on 29Jan2021 with negative results.
Massive chest pain, tightness, pressure, stabbing pain.  Leg swelling.  Arm redness.   Shortness of breath.  Heart fasiculations and pulsations.
This is a healthy 31 year old g3p2 at 15 weeks 5 days by 1st tri u/s.  Uncomplicated pregnancy, hx 2 prior vaginal deliveries.  Healthy babies,  7 and 8#.   Has hx PCOS and takes metformin, no other medical problems.  Patient had a covid vaccine and developed a herpes zoster eruption 48 hours later.  She has classic zoster eruption on her right flank.  There is a cluster of bright red vesicles in a dermatomal distribution on her right flank.  She had classic prodromal sx with itching and burning in the area for a few hours before the rash was visible.
Information has been received from a health professional concerning a 4-year-old female patient who on approximately 04/18/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  Concomitant therapy included diphtheria toxoid/pertussis vaccine/teta (manufacturer unknown).  Approximately 6 hours post vaccination the child developed a fever of 103F.  No other information was provided.  Unspecified medical attention was sought.  Additional information has been requested.
Had fever 24 hours after MMR and on and off for 5 days after that. Also had rash on cheek with some swelling of face and neck. Reported staring episodes and acting "loopy" and out of it on and off.
Day 6 and 7 after Dose 1: mild chills, aches,headache Day 8: red circle at injection site with swelling and hot to the touch, mild chills, aches,headache Day 9-12: symptom improvement Day 13-14: moderate chills, aches, low grade temp
Only first dose was administrated on 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd March 2019, batch number 4g58x, expiry date 9th July 2021).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter consented to follow up.
Mom states infant got shots on 10/03/02 about 3 or 4 pm, Started Tylenol infant drops and gave every 4 hrs. About 9 pm last night infant appeared sluggish-no increased temp, This am temp was 99.5 at 9 am and 101.3 at 11:00 am, After Tylenol every 4 hrs, states infant won't take bottle sleepy and sluggish, Mom went to doctor's office and will see baby at 2:oo pm today. Mom states baby was well before receiving immunizatioins. Saw doctor 10/09/02, Highest temp 102.5 , Baby developed diarrhea over weekend, Now back on formula.
Information has been received from a registered nurse concerning a 1 year old male who was vaccinated with a dose of varicella virus vaccine live.  Concomitant therapy that day included measles-mumps-rubella vaccine.  Subsequently, 3 weeks after vaccination, the patient developed a vesicular rash in his diaper area.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information received from a healthcare professional indicated that the office did not have any additional information about this patient.  No additional information is expected.
olecranon bursitis / left arm / also present in right arm; exacerbation of osteoarthritis in right arm; skin rash; I could hardly move my arm; its almost like a serum sickness; This case was reported by a consumer via call center representative and described the occurrence of olecranon bursitis in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID 19 VACCINE.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 7 days after receiving Shingrix, the patient experienced olecranon bursitis, osteoarthritis aggravated, rash, mobility decreased and serum sickness. The patient was treated with celecoxib (Celebrex), paracetamol (Tylenol), aspirin and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the olecranon bursitis, osteoarthritis aggravated and rash were not recovered/not resolved and the outcome of the mobility decreased and serum sickness were unknown.   It was unknown if the reporter considered the olecranon bursitis, osteoarthritis aggravated, rash, mobility decreased and serum sickness to be related to Shingrix.  Additional details were provided as follows: The reporter reported for himself. The patient received 1st dose of Shingrix 2 to 3 weeks ago on left arm. The patient about 7 days later had experienced olecranon bursitis (started with left arm, but now also present in right arm), skin rash, and exacerbation of osteoarthritis in right arm. The patient also stated that olecranon bursitis was present in the same arm the vaccine was given. The patient also had rash that does not look like chickenpox. The patient could hardly move his arm. he also stated that no side effects in lower extremities. The patient felt like a serum sickness. The patient received Covid vaccine in February. The patient mentioned that side effects were present but getting better. The patient was using ice, Celebrex, Tylenol as needed, and took aspirin for heart. The patient was not worried about the side effects because it was getting better, but would discuss with his healthcare provider on his next appointment. The patient did not have lot number or expiration date of Shingrix. No other information was provided. The reporter consented to follow up.
RA swollen with redness x 24 hrs - 4 1/2" by 4 1/2" hot to touch with no c/o pain getting worse over 24 hrs. Keflex 250/5, Zyrtec qd, Benadryl (post swelling).
This spontaneous case reported by a consumer, describes the occurrence of hypoesthesia (face and body are numb) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On Mar 5, 2021, patient experienced hypoesthesia (face and body are numb). At the time of the report, hypoesthesia (face and body are numb) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Reporter did not allow further contact.
Month after vaccine she would occasionally she would have dizziness and she would take a tylenol but the feeling still comes and goes
10/31/07 Mom called mid morning stating arm was red and swollen at site of Varivax. Shot size of a lemon and warm to touch. 11/1/07 mom called requesting appointment for swelling and redness at site. Rx given Bactrim
Fever in young infant: 55 days old, evaluation resulted in Enterococcal faecalis bacteremia. Infant hospitalized for 3 days and send home on antibiotics.
Initial unsolicited report received from a non-health care professional (pharmacy manager) on 16 October 2015. This case involves a 72-year-old male patient, who was vaccinated with second dose of  FLUZONE HD (batch number: UI477AA, Expiry date: 20 May 2016) (dose and route of administration was not reported) in left deltoid on 01 October 2015. The patient had received previous dose of FLUZONE HD on an unspecified date. It was reported that patient had no illness at the time of vaccination. Medical history and concomitant medications were not reported. It was also reported that patient had no known allergies. On 01 October 2015, same day following vaccination, the patient had bleeding at the site. On  unspecified date, patient had experienced pain and quarter size bruise at the injection site. It was reported that no laboratory investigations were performed and corrective treatment was not reported. At the time of this report, the patient was not recovered from the events. Documents held by sender: none.
The vaccines were applied to patients after being refrozen; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Medical history was not provided.     On 23-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen). On 23-Jun-2021, PRODUCT STORAGE ERROR (The vaccines were applied to patients after being refrozen) 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.   No concomitant medication reported. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up information was received include no new information.
Expired Flulaval administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 93Z32, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th September 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Sept-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with cases US2022134438, US2022134439 and US2022134440 reported by same reporter for different patients. Additional supportive information: The patient received an expired dose of Flulaval quadrivalent, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022134438:Same reporter US-GSK-US2022134439:Same reporter US-GSK-US2022134440:Same reporter
Stage IV COPD with chronic hypercarbic and hypoxic respiratory failure.   He is quite physically declining at this time.  He is constantly anxious from breathlessness.       Since the pulmonary prognosis is much worse, I will recommend palliative care consult to explore his options. COPD cachexia.  Very poor prognostic sign.  Increased chest pain, dizziness, no COPD exacerbation since October 2020.   Now hospice patient.   Oxygen dependence Right upper lobe lung mass consistent with malignancy Respiratory failure: hypoxic and hypercapnia Pulmonary cachexia Chronic anxiety
Patient was administered Kinrix in error which is not recommended for this age group. Parents were made aware. Patient was asymptomatic.
Fever (as high as 101.8), rigors, joint/muscle aches, headache, lethargy, malaise, injection site pain & swelling
COVID-19; COVID-19; Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Jan2022, outcome "not recovered", described as "Vaccine brand other: Moderna; Vaccine brand: Pfizer/BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2023) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19Apr2023 to 24Apr2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202300175660 same  patient/reporter, different drug/AE;