chrisvoncsefalvay/vaers-outcomes huggingface dataset:
his arm was just sore for a day; This is a spontaneous report from a contactable healthcare professional (patient). A male patient of an unspecified age received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiration date were not provided) solution for injection, via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he received the first dose of the COVID vaccine on 21Jan2021 (12 days ago). He stated that he was fine, his arm was just sore for a day on an unspecified date in 2021. The outcome of the event was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.
SWEATING; fever; soreness in the arm  after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE PAIN (soreness in the arm  after the first dose) and HYPERHIDROSIS (SWEATING) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE PAIN (soreness in the arm  after the first dose). On 17-Mar-2021, the patient experienced HYPERHIDROSIS (SWEATING). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Mar-2021, PYREXIA (fever), VACCINATION SITE PAIN (soreness in the arm  after the first dose) and HYPERHIDROSIS (SWEATING) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.
Redness, tenderness, induration, hardness, itchiness on the injection site.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe
Patient states that her veins in her hands swell up to three times the normal size that they usually are every time she has received a vaccine. She says that the swelling starts about 12 hours later after receiving the shot.
Fluttering twitches in lower arm and near knee Mild pulsing pain in back of head on 5/1/2021 at about 7 am
Pain and swelling at injection site.  Fever Body aches *diagnosed with shingles 1 week later Shingles symptoms started 2 days after vaccine.
DEHYDRATION DUE TO COLON CLEANSING; SWEATY; WEAK; LIGHTHEADED; STOMACH IN PAIN AND UNCOMFORTABLE; This spontaneous case report (PVX2019-2896) was received from a consumer on 22-Nov-2019. Additional information was received on 27-Nov-2019. It described a female consumer who developed dehydration due to colon cleansing (PT: Dehydration), felt sweaty (PT: Hyperhidrosis), weak (PT: Asthenia), lightheaded (PT: Dizziness), stomach in pain and uncomfortable (PT: Abdominal pain upper), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took last dose of Vivotif on 19-Nov-2019 in the morning. On the same day, in the afternoon she had a scheduled colon cleansing/colon hydrotherapy for cleaning her colon. She reported that during and after the hydrotherapy she started feeling sick with the symptoms of weak, sweaty, lightheaded, and stomach in pain and uncomfortable. She also reported that all the symptoms were possibly due to hydrotherapy and she developed dehydration due to the colon cleansing, as she did not experience any side effects after taking first three doses.  Action taken with Vivotif with respect to the reported events was not applicable.  The consumer had recovered from the reported events on 19-Nov-2019.  Company's Comment: In this case, it was reported that the consumer developed dehydration due to colon cleansing, felt sweaty, weak, lightheaded, stomach in pain and uncomfortable after intake of Vivotif. The consumer got a colon cleanse. There seems to be a temporal association between the intake of the vaccine and the events. Also, the causal role of vaccine cannot be ruled out. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer developed dehydration due to colon cleansing, felt sweaty, weak, lightheaded, stomach in pain and uncomfortable after intake of Vivotif. The consumer got a colon cleanse. There seems to be a temporal association between the intake of the vaccine and the events. Also, the causal role of vaccine cannot be ruled out. Hence, the causality of the events with Vivotif is assessed as possible.
pt recv vax 22JUL96 & began itching on 25JUL96 & 26JUL had swollen up to 1/2 dollar size, red & hot to touch;put alcohol on it only
child was given expired product with no reported adverse event; Initial information received on 20-Dec-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves a 1-year-old male patient who was given expired product, DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE for Prophylactic vaccination and Pneumonia vaccine.  On 20-Dec-2022, the patient received dose 4 (0.5ml total) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Strength: standard, formulation: unknown) (lot number: UJ622AAA and expiry date: 07-Dec-2022) via intramuscular route in the left thigh (left leg) for Immunization and on the same day child was given expired product with no reported adverse event (expired product administered).  Reporter wanted to know next steps.   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient standing up in hallway during checkout and stated that she didn't feel good. She leaned over on her mother and passed out, she was assisted by her mother and the nurse to the floor. She immediately regained consciousness and was assisted into a chair for monitoring. She reported nausea and began dry heaving. She had not eaten anything prior to coming into clinic. Vitals signs assessed for 30 minutes, felt better and released home with mom.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 59-year-old male patient who received SHINGRIX for prophylaxis. On 19th October 2018, the patient received the 1st dose of SHINGRIX. On 20th October 2018, 1 days after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the patient experienced feelings of weakness. On an unknown date, the outcome of the erythema of extremities and feelings of weakness were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and feelings of weakness to be related to SHINGRIX. Additional details were reported as follows: The reporter was a patient. The patient received the SHINGRIX vaccine on left arm and developed redness at the injection site. The redness was the size of a baseball and increased in size from the shoulder to the elbow before going away. The patient stated that he also felt weak after receiving the vaccine. The reporter consented to follow up.
developed dizziness, "throat was closing" and pruritus Given Benadryl 25 mg/ IM Sent home improved.
Pain at injection site General muscle aches Swelling and tenderness over left collarbone  Fatigue  Possible fever
pt recvd vax 13MAR95 6PM; on 15MAR95 inc swelling, redness, warm to touch; swelling measured 5"x 4" on 16MAR95; redness measured 3"x2" on 16MAR95; warm to touch also noted;
that afternoon nonstop crying lasting longer than 4hr;would not take bottle of formula nor cereal;slept that noc nl;
Individual received a booster dose on 1/24.  Second Pfizer shot was received on 10/7/21.  did not catch the mistake that this shot was 2 months early.
After receiving the 2nd Covid vaccine I developed pulsatile tinnitus in my right ear. I have seen an ent, primary care doctor and cardiologist. The ent advised it could be due to the Covid vaccine.
Whole body pruritus without rash; started on hydroxyzine, with significant improvement in symptoms. CBC, CMP, TSH all normal.
Patient became flushed in the face, felt hot, heart was racing and felt as though her mouth and tongue felt thick (not completely swollen and patient was able to continue to breathe).
The pt experienced stomach cramps, difficulty with defecation, stool always very black mixed with blood. Baby does not gain weight. Passing stool is a serious problem.
Body pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 MYALGIA (Body pain). At the time of the report, MYALGIA (Body pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported     Reporter did not allow further contact
Diagnosed with COVID shortly after; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A female patient of an unspecified age received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0151, Expiration Date: Jul2021) via an unspecified route of administration on 09Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 12Apr2021 the patient experienced adverse event and diagnosed with COVID-19 shortly. The patient underwent lab tests and procedures which included covid-19: positive on 12Apr2021. The outcome of the events was unknown. The seriousness of the event COVID-19 was reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Red, swelling about 10 cm, itching, hot to touch started on 03/08/2021 - present No treatment, keep cool
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu-like symptoms) and PRODUCT DOSE OMISSION ISSUE (2nd shot of vaccine not received >42 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INFLUENZA (flu-like symptoms) and PRODUCT DOSE OMISSION ISSUE (2nd shot of vaccine not received >42 days). On 02-Feb-2021, PRODUCT DOSE OMISSION ISSUE (2nd shot of vaccine not received >42 days) had resolved. On 10-Feb-2021, INFLUENZA (flu-like symptoms) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Influenza virus test: negative (Negative) Negative. On 04-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was unknown.
10/20/04 Sleepy; not as alert. 10/21/04 Arousable, no behavior issues; increased lethargy. 10/26/04 Lethargic; unable to grasp objects or feed self. Slight hand tremor visible. Oxygen started. Transferred to hospital for evaluation. Medical Record received on 2/02/2005 states UTI. Follow up 01/19/05: The patient has not recovered, he requires more assistance with activities of daily living, continues to have some confusion.
Only received one dose/ not received her second dose because she feels she missed the call to schedule; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Only received one dose/ not received her second dose because she feels she missed the call to schedule) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (bad arthritis and would not move very well).    On 22-Mar-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 (Only received one dose/ not received her second dose because she feels she missed the call to schedule). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Only received one dose/ not received her second dose because she feels she missed the call to schedule) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.  The patient did not have her second dose as of 02-Jul-2021.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up report received included information about current condition: The patient did not have any adverse event after first dose and was doing fine.
This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program COVAX US support. A male patient of an unspecified age received the first dose of bnt162b2 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had his first dose of the covid-19 vaccine on 31Mar2021 and since then (2021) has been taking Nitrofurantoin 100mg for a bladder infection. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever of 102 occuring two days after vaccination. Mother noted some rapid breathing and wheezing at onset of fever. Pt was seen at Redimed 8-18-08. At time of office visit fever was down to 99 because mother had given child tylenol. There was no rapid breathing or wheezing at time of office visit either.
Moderna COVID 19 Vaccine EUA Chills fever sweating aches (joint and muscular) headache nauseated exhaustion  pain at the injection  site
Information has been received from a Registered Nurse concerning a 58 year old female patient with generalized convulsive epilepsy and no drug reactions/allergies who on 28-SEP-2011, was vaccinated with a second dose of PNEUMOVAX 23 (Lot # 670187/0895AA; Exp. Date: 12-NOV-2012) 0.5 ml, intramuscularly in the right arm. Concomitant therapy included FLUVIRIN. The registered nurse reported that the patient experienced adverse reactions after receiving PNEUMOVAX 23. On 28-SEP-2011, the patient was experiencing right arm pain from the injection site down to her elbow that she rates as an 8-10 on a pain scale of 1-10 (where 10 was the most severe pain). The patient had very limited motion in her right arm, could not drive her car and had missed her work. The nurse stated that this patient had received a dose of PNEUMOVAX 23 at some unspecified time in the past. The patient sought medical attention visiting a urgent care clinic. VICODIN was given for the treatment of the events. It was unspecified if laboratory tests were performed. The registered nurse also reported that the patient stated that the VICODIN was not helping her with the pain. At the time of the report the patient had not recovered. The right arm pain from the injection site down to her elbow and the limited motion in her right arm were considered to be disabling by the registered nurse. A lot check for lot # 670187/0895AA has been initiated. Follow-up information has been received via telephone call from the registered nurse who stated that the patient was still having problems and was currently undergoing therapy (unspecified). Follow-up information has been received from the registered nurse concerning the patient. The patient's concurrent condition also include osteoporosis. She had no known drug allergies. The patient received the first dose of PNEUMOVAX 23 IM in right deltoid (number of prior dose also reported as 1 previously) on 28-SEP-2011. The patient had right shoulder pain. The pain was sharp and aggravated by movement. The pain was relieved by rest and "alier". She had decreased mobility and had difficulty lifting arm. At the time of reporting the patient had not recovered and still complained of pain in arm upon movement. Pain rated 5.6. Upon internal review, right shoulder pain was considered to be disabling. Additional information has been requested.
2ml of normal saline was used to reconstitute the vaccine instead of 1.8ml. No adverse effects reported.
slight nausea noticed when I woke up in the middle of the night; still have it (1047 CST).  Slight headache this a.m.
I have NEVER had any ear problems in my entire life, including no was problem and I woke up with Sudden Hearin Loss, only 35% ability to hear in right ear.
1 st Covid vaccine.-Arm ached for about a wekk, then on 9th day following vaccine, had about a 2 inch rash along with hives, that lasted about 3-4 days before disipating. 2nd Covid vaccine on 3/29/21 - whole body ache for about 2 days, however, there is prolonged aches  in left rib and left hip.
Information had been received on 02-MAY-2017 from a nurse who reported that on 01-MAY-2017 a 12-month old female patient was inadvertently administered a dose of ZOSTAVAX with sterile diluent instead of VARIVAX (lot# M033907, expiration 20-JUL-2018). Nurse confirmed administration was the result of "human error" and not product confusion. No adverse effects reported. Nurse had requested to be contacted for all correspondence. Field employee called to confirm that the case had been reported by the physician's office. No AE/PQC reported. Additional information has been requested.
This spontaneous report was received from a physician via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, (lot number and expiry date was not provided). On an unknown date, the patient developed rash on his buttocks. The outcome of the event was unknown. The patient sought medical attention. Additional information has been requested.
Received varicella vaccine 11/12/08. 11/26/08 developed few vesicles, 11/23/08 headache. 12/1/08 admitted to hospital diagnosed with chicken pox, spinal tap & CT head (-) (CT head also negative 11/24/08). 12/3/08 pt discharged home, headache resolved 12/2/08 lesions crusty potential receptors made aware. 12/11/08-records received for DOS 12/1-12/3/08-DC DX-chickenpox activation. Two to four weeks after vaccination developed headache, fever, chills and rash on face and abdomen.
Pt received ZOSTAVAX on 1-10-11 then developed suspicious rash (seven) 7 days later (chicken pox like) verified by MD.
The patient presented 8/12/21 (vaccinated 8/19/21) with a rash around the upper chest/neck area.  The patient stated it started forming this morning.  He mentioned he has a history of rashes similar in appearance, but has not had one in several years.  The rash did not itch "yet" he stated.  I recommended the patient take benadryl and monitor the rash for worsening.  I also directed the patient to seek immediate medical attention if began to feel like he could not breathe.  The patient is feeling okay, but wanted to make sure the rash was documented as he feels it is related to his second dose of Moderna.
This spontaneous report was received from a nurse refers to a 4 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 14-SEP-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044397, expiry date: 20-JUN-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
Extreme Fatigue, Head-to-toe muscle aching, couldn't get out of bed without help due to weakness, eventual bright red rash on arm at injection site:  hot to the touch and very sore.  Had no use of injected arm for 48 hours. Generally felt very ill for two days.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 04-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # U014656 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes; additionally on 26-MAY-2022 experienced an additional temperature excursion of 35.2 F for 56 seconds. If a digital data logger was involved was not reported (product storage error).   Consequently, on 27-MAY-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number reported as U026664 confirmed as valid, expiration date reported and stablished as 24-FEB-2023) administered orally as prophylaxis (formulation, strength, dose, vaccination scheme were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103: