chrisvoncsefalvay/vaers-outcomes huggingface dataset:
head numbness; stutter; twitch; shaking; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (head numbness), DYSPHEMIA (stutter), MUSCLE TWITCHING (twitch) and TREMOR (shaking) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 041c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (head numbness), DYSPHEMIA (stutter), MUSCLE TWITCHING (twitch) and TREMOR (shaking). At the time of the report, HYPOAESTHESIA (head numbness), DYSPHEMIA (stutter), MUSCLE TWITCHING (twitch) and TREMOR (shaking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: low (Low) blood pressure drop.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Pt recv vax on unspecified date; on unspecified date pt exp rxn of injection site of erythema,pain,pruritus,warmth &swelling from shoulder to elbow; pt tx=antihistamine &warm compresses.
Wrong dose given to pt. No symptoms at this time.  5-11 yr vaccine given to 2 yr old pt.
Myalgia injection site soreness, chills Narrative:  Employee reports body aches, chills, fatigue, and "soreness". Reports using Tylenol (no dose/frequency provided).
Headache that does not respond to tylenol. Still have a headache 36 hours later.  Fever lasting several hours starting at 11PM 5/7 and coming and going a few hours at a time on 5/8.   Body aches and chills all day 5/8.   Chills. excessive sweating but no fever morning of 5/9.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 40 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 17Apr2021 as dose 2, single (Lot number: ER8727), in left arm and on 17Jan2022 as dose 3 (booster), single (Lot number: FJ6369), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which includes Paxlovid (COVID 19 Treatment) from 19Feb2023 to 24Feb2023.
This spontaneous report as received from a physician refers to a 6 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 03-JUL-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 49 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012766.
Inflammatory bowel symptoms such as severe pain and bloating on 2 occasions lasting for 3-5 days
he got sick; diarrhea; Throwing up; Head hurt; could not get out of bed after second dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (he got sick), DIARRHOEA (diarrhea), VOMITING (Throwing up), HEADACHE (Head hurt) and FATIGUE (could not get out of bed after second dose) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (he got sick), DIARRHOEA (diarrhea), VOMITING (Throwing up), HEADACHE (Head hurt) and FATIGUE (could not get out of bed after second dose). At the time of the report, ILLNESS (he got sick), DIARRHOEA (diarrhea), VOMITING (Throwing up), HEADACHE (Head hurt) and FATIGUE (could not get out of bed after second dose) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non significant followup recieved report added On 06-Aug-2021: The follow up document was received and had non significant information
1. Sore arm started 3/12 in the afternoon. As it progressed, became hot, red and painful. As of today (3/16), still red and tender. 2.Fever began 3/13 in the afternoon. The high was 101.8 Fahrenheit and it lasted for 2 days. There is a residual low fever. 3. Chills started 3/13 in the afternoon. Lasted off and on for 12 hours. 4. Headache has been intermittent since 3/13.  5. Fatigue off and on since 3/13. 6. Joint pain on 3/13.
Patient came with complaints of allergic reaction to flu vaccine administered on 12/6/04. Patient complained of itchy rash at injection site. Patient returned to clinic 1/3/05 for treatment. Urticaria noted by patient within 1 hour of injection flu vaccine. 1/3/05 Treated for generalized rash.
Pain in armpit; swelling in armpit; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (Pain in armpit) and PERIPHERAL SWELLING (swelling in armpit) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced AXILLARY PAIN (Pain in armpit) and PERIPHERAL SWELLING (swelling in armpit). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, AXILLARY PAIN (Pain in armpit) and PERIPHERAL SWELLING (swelling in armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up information received on 12 May  2021 contain information: Reporter contact details updated.
Symptoms started with sore arm at injection site 1 hour after shot. Within 12 hours got chills, low fever 100.5~, sore arm, nausea, blurry vision, body pain all over, rash on left forearm that started to spread all over, day 2 rash spreading more around the arm and moving upwards on forearm and itchiness intensified even with Claritin and hydrocortisone. Thursday morning started having difficulty breathing in deeply with chest pain and throat closing up so headed to ER.
Awakened with severe fatigue, then 2 days later achy all trigger points (of fibromyalgia) neck and back. Finally 1 wk later, feels fine(?) Plans to do Hep B in Feb 03.
After 2nd dose (May 3rd)...May 6th started to notice swelling in top half of both hands, stomach and chest developed hives and a rash. Not very bothersome, hands are very warm and extremely inflamed. Took allergy medications, they haven't done anything. No reactions after 1st dose, this is all after 2nd dose.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 79-year-old male patient who received SHINGRIX. Co-suspect products included Pneumococcal Vaccine. On 8th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) and Pneumococcal Vaccine. On 8th May 2018, several hours after receiving SHINGRIX and not applicable after receiving Pneumococcal Vaccine, the patient experienced shivering, feeling cold, touch sensitivity increased and injection site pain. In May 2018, the patient experienced injection site erythema. On an unknown date, the outcome of the shivering and feeling cold were unknown and the outcome of the injection site erythema, touch sensitivity increased and injection site pain were not recovered/not resolved. The reporter considered the shivering, feeling cold, injection site erythema, touch sensitivity increased and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's spouse. The patient was an optometrist. On Tuesday around 9:30 am, the patient received 1st dose of SHINGRIX vaccine on the left arm. On the same day, the patient received Pneumococcal vaccine of unknown manufacturer in the opposing right arm. On the same day, at night, the patient experienced shivering and felt cold with chills. There was still a red area oblong about 4 inches by 6 inches on the left arm where the vaccine had been administered which is currently sensitive to being touched. The reporter called to inquire if this could be an allergic reaction or adverse reaction and whether or not her husband should receive the second dose in the series which was already scheduled. The product packet insert (PI) was discussed during the call, and her specific inquiry was referred to the responsible healthcare professional. The patient's injection site got a little pink on the right arm described as hardly being any reaction at all in comparison to the other left arm's red area where the SHINGRIX vaccine had been administered. The pink area on the right arm injection site was improved. The reporter indicated she had no further time to discuss and then needed to end the call. It was okay to contact the reporter via letter with further questions. The reporter said she tried to contact GSK a day before the date of reporting, to discuss but only got a message that the GRC was in a meeting and was unable to speak with anyone. However, no service request (SR) for this reporter was found. Due to time constraints, it was unknown if the patient grants permission to contact his responsible healthcare professional or not. No further information was available beyond what was documented above, due to time constraints. It was unknown, if the reporter considered the shivering, feeling cold, injection site erythema, touch sensitivity increased and injection site pain to be related to SHINGRIX.
no adverse events noted. patient was 16 at time of first vaccination, 17 at time of second
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63-year-old female patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6199), on 30Mar2021 as dose 2, single (Lot number: EK8733) and on 05Nov2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid from 17Aug2022 to 22Aug2022.
"Pfizer-BioNTech COVID-19 Vaccine EUA".  Symptoms: Tiredness throughout day at approx 2 hrs after vaccination. Felt feverish around midnight, headache, some nausea, pain on arm where vaccination was applied, overall upper discomfort, joint pain (shoulders) and kind of disoriented.  Took Tylenol Extra Strength, 500mg, to ease the discomfort.
10 min Strong Metallic taste in mouth- faded after 3 hrs and resolved over 5 day period. 10 min sharp tingling sensation tongue lips throat resolved within 1 hour 20 min sharp pain in right side  30 min numbness right side, mostly tight leg ;  some neck, right arm, lasted approx 24 hours  3 hrs heart rate 220 bpm - ranged 154-225 bpm for approx 4 hours;                  intermittent heart racing 170-190bpm for brief (10 min) periods over next week  Day 2 Headache and numbness R side  Sleep cycle opposite of normal 3 weeks wake at 3 am sleepy 3pm (unusual unknown if related) Next 2 Menstrual cycle Unusually heavy / clotting and shortened.
This case was reported by a consumer via call center representative and described the occurrence of cold sores lip in a male patient who received SHINGRIX for prophylaxis. On 8th October 2018, the patient received the 1st dose of SHINGRIX. On 9th October 2018, 1 days after receiving SHINGRIX, the patient experienced cold sores lip. On an unknown date, the outcome of the cold sores lip was unknown. It was unknown if the reporter considered the cold sores lip to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The next morning after receiving SHINGRIX, the patient developed a cold sore on his lip. The patient has denied permission to contact their physician.
This spontaneous report as received from a registered nurse refers to a 4 years old patient of unknown gender. On 10-APR-2014 the patient was vaccinated with M-M-R II (therapy type: rHA, batch number: J005846, lot: 1681AA, expiry date: 17-APR-2015) that on 03/03/2014 was exposed at an unsupported temperature excursion (temperature range: 45F, time frame: 24h). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by nurse, via consumer and described the occurrence of dizziness in an unknown number of subjects of unspecified ages and gender who were vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. In 2007, the subjects received unspecified doses of Influenza vaccine (unknown). The reporter stated he "talked with a nurse who stated she had patients who experienced dizziness, inner ear problems, nausea and vomiting after receiving the flu shot this year". At the time of reporting the outcome of the events were unspecified.
Pt states that he is fully vaccinated for COVId with Pfizer. Unknown dates of vaccination. Pt hospitalized with shortness of breath and tested positive for COVID upon admission
20 minutes after receiving vaccines the client noted itching of throat and right ear. Develped Dry cough. Given Benadryl elixir 25 mg P.O. Symptoms subsided after 15 min. Observed an additional 20 min. then released. No further symptoms reported. Vital signs remained unchanged. No dyspnea or Shortness of breath, swelling, hives or wheezing.
Vaccine administration error.  It is suspected that this vaccine was administered via a 1/2" needle syringe instead of IM with a 1" needle syringe.
Swelling at injection site. Diffuse maculosquamous eruption of abdomen and chest. Generalized fatigue  and malaise.
Headache which lasted four or five days; Administration date 27Sep2021, dose number=3; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 27Sep2021 at 11:00 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); both from an unknown date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 09Feb2021 at 11:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. On 27Sep2021 at 11:00, the patient had "administration date 27Sep2021, dose number=3". On 28Sep2021, the patient experienced headache which lasted four or five days. Therapeutic measures were not taken as a result of the event headache which lasted four or five days. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache which lasted four or five days was recovered on an unknown date in Oct2021. The clinical outcome of the event "administration date 27Sep2021, dose number=3" was unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up
Blood pressure low; Rash on the stomach, chest, arms, thighs, toes, legs and face; Chills; Tremendous headache; Fever of 100.5; Weakness; Collasped; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Collasped) and HYPOTENSION (Blood pressure low) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Collasped) (seriousness criterion medically significant) and ASTHENIA (Weakness). On 30-Mar-2021, the patient experienced CHILLS (Chills), HEADACHE (Tremendous headache) and PYREXIA (Fever of 100.5). On 01-Apr-2021, the patient experienced HYPOTENSION (Blood pressure low) (seriousness criterion hospitalization) and RASH (Rash on the stomach, chest, arms, thighs, toes, legs and face). On 29-Mar-2021, LOSS OF CONSCIOUSNESS (Collasped) had resolved. At the time of the report, HYPOTENSION (Blood pressure low), ASTHENIA (Weakness), CHILLS (Chills), HEADACHE (Tremendous headache) and PYREXIA (Fever of 100.5) outcome was unknown and RASH (Rash on the stomach, chest, arms, thighs, toes, legs and face) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Pyrexia: 100.5 Patient experienced fever of 100.5..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included diphenhydramine and acetaminophen.   On 01 Apr 2021, the patient experienced a fever of 100.5 degree Fahrenheit and noted a rash to the stomach. The patient then called 911. The paramedics checked the patient out and noted patient's blood pressure to be low and was taken to the hospital.   On unknown date, the patient was discharged home after receiving some unspecified medications.  On 02 Apr 2021, the patient reported the rash was full blown, was on the stomach, chest, arms, thighs, toes, legs and face. The rash subsided on unknown date.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Vax on 10/19. Noticed knot which appears as a sterile abscess on L deltoid area. No fever. No soreness or infect noted.
First dose 12/08/2021 without any side effect, but 2 months after the second dose urticaria developed on my head and neck the. Developed to my extremities. 4 weeks later became more localized on my face and back intermittently.  No other signs of allergy.
Initial unsolicited report received from consumeron 27 October 2015. This case involves a 67-years-old male patient who was vaccinated with first dose of FLUZONE HD (batch number was unknown, dose, expiry date were not reported) intramuscularly in left deltoid on 26 October 2015 at 2 PM. Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. Concomitant medications were not reported. On 26 October 2015, 07 hours (at 9 PM) following the vaccination, the patient had developed pain in stomach, sweating thru pajamas, chills, fever and headache. At the time of reporting all symptoms were subsided. Laboratory data and corrective treatment was not reported. The patient was not recovered from the events. List of documents held by sender: none.
Over time experienced increased joint pain in hands and R hip.  Had bilateral carpal tunnel surgery due to moderate-severe carpal tunnel.  Went through massage and acupuncture initially to solve pain.  I have not had treatment yet for my R hip.
sore arm; little fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization, reaction(s): "sore arm", "little fever"; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization, reaction(s): "sore arm", "little fever"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "sore arm", "little fever"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "sore arm", "little fever".  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever".  Additional information: Patients wife and patient took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. They also had one bivalent booster. They experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. They were eligible for the second bivalent booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.