chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx. 3 hours post vaccination patient began to develop hives on the LEFT side of face extending along jaw-line from chin to eyebrow. Started with scratchy throat and swelling of her lips. Patient immediately self administered 50 mg PO Benadryl, responded well to treatment.
pt recv vax 1JUN95 & 24MAY96 pt devel chickenpox;No further details were provided
they administered the pentacel vaccine to patient. However the vaccine was not mixed. The caller advised the patient only received the powder portion, with no adverse event; Initial information was received on 11-Jan-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age/gender patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] however the vaccine was not mixed. the caller advised the patient only received the powder portion, with no adverse event.  The patient's past medical history, medical treatment(s),concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (dose, formulation, strength, lot number, expiry date, route, administration site: Unknown) for prophylactic vaccination (Immunisation) was not mixed. the caller advised the patient only received the powder portion, with no adverse event (product preparation error) (same day latency).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event they administered the pentacel vaccine to patient. however the vaccine was not mixed. the caller advised the patient only received the powder portion, with no adverse event.  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 guidelines. 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 passed out few minutes after receiving his vaccine. He fell and was wake soon after. When I arrived he was wake. He had a headache most likely from the fall. He felt thirsty and a little hungry. We had him sit on a chair. I gave him water and sugar cookies. He felt better after few minutes and they left.
My epoglottis began swelling about 8-10 hours after the shot.  It was minor, and I did not see a doctor., nor did I take any meds or treatment The swelling was gone by the next morning.
Event occurred after 2nd vaccine. First vaccine was on 1/14/21 and the second one on 2/11/21. Pt tested positive for COVID-19 on  11/21/21.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-MAY-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 20-MAY-2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Large local reaction. 1 x 4 cm welt 5 x 7 cm redness at injetion site.  Required additional doctor office visit.  Treated with Benadryl as an allergic reaction
Experienced shoulder pain day of vaccination without improvement and limited mobility from date of vaccination. Has seen nurse practioner who prescibed 600 mg of IBU twice daily and is currently doing physical therapy. Pt noticed shot had been given higher than usual.
Hello, I received the Shingrix vaccine on 13 Dec via a Clinic and experienced the following sides effects, moderate pain in my right arm, hives, warmth /redness and swelling at the injection site that spread down to my elbow, fever, chill, muscle pain nausea and stomach pain. The signs/symptoms lasted for 4 days and today I'm feeling much better today.
Tender raised red bump at the injection site.  Bump is hot to the touch.   Was present the next morning after the shot.  Bump is less than two inches in diameter.
Seizure x 2, prolonged seizures, required multiple doses of rectal DIAZEPAM to stop. Admitted to hospital. Normal labs/Head CT but very mild temp to 100 degrees F was noted.   11/3/08-ED records received for DOS 10/15/08-presented with C/O witnessed new onset seizure with fixed gaze and right side arm/leg tickling. Generalized tonic-clonic seizure. Afebrile in ED. Discharged home from ED. DX-Seizure.
arm pain; joint pain; headaches; loose bowels; vomiting; chest discomfort; nausea; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm, joint pain, headache, loose bowel, vomiting, chest discomfort and nausea. On an unknown date, the outcome of the pain in arm, joint pain, headache, loose bowel, vomiting, chest discomfort and nausea were unknown.   It was unknown if the reporter considered the pain in arm, joint pain, headache, loose bowel, vomiting, chest discomfort and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and had pain in arm first few hours after injection. Followed by intensive joint pain and headache.  No history of headaches. After 12 hours loose bowels with uncontrolled vomiting for next 2 days. Minor chest discomfort. Better on 4th day with mild nausea. The patient was on brat diet.  The patient was little worried about possible reaction to 2nd dose.
Patient has had arm pain and shoulder pain since the injection on 12/9/22. Unable to sleep on arm, raise arm above head, or reach backward with that arm. Difficulty lifting objects up with that arm.
Patient found deceased in his home. He had reported flu like symptoms to a family member via phone day before.
Information has been received from a physician who was told by another physician that a 40 year old patient was vaccinated with two doses of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. It was reported that the patient "did not respond" after a month to the two doses of measles virus vaccine live + mumps vaccine live + rubella virus vaccine live. No further information available at this time. Unspecified medical attention was sought. Additional information has been requested.
Pain, swelling of left thigh, not moving left leg, could not change position in lying, sleep disturbance.
Beyond sick; Fever; Chills; Arm hurt; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Beyond sick), MYALGIA (Arm hurt), FATIGUE (Felt tired), PYREXIA (Fever) and CHILLS (Chills) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced MYALGIA (Arm hurt) and FATIGUE (Felt tired). On 10-May-2021, the patient experienced ILLNESS (Beyond sick), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 11-May-2021, ILLNESS (Beyond sick), MYALGIA (Arm hurt), FATIGUE (Felt tired), PYREXIA (Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication was unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-127663 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-127663:fiancé case
Began noticing itchiness of the hands arms and shoulder on the morning of 1/16. Itchiness has continued on since 1/16 intermittently. On 1/19 it was noticed that injection site was red,  slightly raised and warm. On 1/19 I also noticed that the armpit of the vaccinated arm felt very sore and tender to touch. On 1/20 that soreness has spread down to elbow and redness has remained at injection site.
The patient inadvertantly received a Hepatitis A vaccine instead of the appropriate Hepatitis B #1 vaccine at 3 months of age.  The patient had no adverse reaction.
Tired; Headache; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 252N2, expiry date 8th March 2022) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 1st November 2019, 2 days after receiving Shingrix, the patient experienced tiredness and headache. On an unknown date, the outcome of the tiredness and headache were recovering/resolving.   It was unknown if the reporter considered the tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient experienced tiredness and headache. The patient planned to contact her physician on an unknown date. The patient consented to follow up. This case has been linked with case US2019199352, reported by the same reporter.
Breakthrough COVID infection admitted with acute hypoxic respiratory failure secondary to SARS-CoV-2
Temperature excursion with no reported adverse event; Administration of punctured Ipol after excursion with no reported adverse event; Initial information received on 13-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA119119 and 2023SA119126.  This case involves a 4 months old female patient and is reported administration of punctured IPV (VERO) [IPOL] after excursion and temperature excursion 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 HIB vaccine CONJ (TET TOX) (Hiberix), pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP); and Rotavirus Vaccine for Prophylactic vaccination.  On 28-Mar-2023, the patient received a DOSE 2 dose 0.5 ml of suspect IPV (VERO) Suspension for injection lot V1B901M expiry date: 06-Feb-2024 via intramuscular route in the right thigh for Immunization or TB skin test.  On 28-MAR-2023 the patient developed a non-serious event "administration of punctured ipol after excursion with no reported adverse event" (poor quality product administered) and on an unknown date temperature excursion with no reported adverse event (product storage error) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.   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 guidelines. 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.; Sender's Comments:  US-SA-2023SA119943:
Bad reaction like had a bad flu/been in bed recovering; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of influenza like illness (received 1st dose on an unknown date, refer case US2022AMR092895).   In June 2022, the patient received the 2nd dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the influenza-like symptoms was recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR092895   Additional Information: GSK Receipt Date: 12-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got his/her shingles vaccine two days ago from reporting and got the bad reaction, felt like had a bad flu. The patient had been in bed recovering. The reporter stated that, he/she was glad that he/she got the vaccine.  The reporter further stated that, he/she rather suffered a few days than getting the shingles. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR092895:Same Reporter
Presented to ER the next day with two tonic clonic seizures per ER note. Treated with ATIVAN and discharged home.
developed initially right knee pain which then a few days later was the left knee and significant pain in the MCP joints of both hands.  Taking a fair amount of Naprosyn for pain relief and presented with tachycardia and hemoglobin of 6.3 from likely GI bleed.
Narrative: Patient was admitted for severe case of COVID-19 despite receiving both doses of his vaccine on 02/10/2021 and 03/10/2021.
Left deltoid local reaction to DTAP (+) cellulitis.  Prescribed Keflex 250mg/5mL, 3/4 tsp per mouth 4 times a day for 7 days.
lower back pain /mild pain/excruciating LBP; muscle pain; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 08:00 at single dose for covid-19 immunization. Medical history was none. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The patient had very unusual lower back pain that started the day after she received the vaccine and persisted over 5 days. The patient received the vaccine the beginning of her 12 hours shift. The following day on 19Dec2020 7:00 AM she woke up with excruciating LBP. Initially she attributed it to some garden work done the day before her shift and assumed it would resolve in 24 hours. 5 days later she still had mild pain, which was a first for she to have it persist this long. She had no other symptoms. She had never been tested for Covid. She wore N95 and face shield with every ER patient encounter and N95 in work area. She had no history of back problems or injury. She was only reporting this as the timing of, severity of, and duration of this muscle pain she was experiencing is perplexing and she was wondering if it has any relation to the vaccine. She thought perhaps her unusual pain symptoms were vaccine unrelated, but she had a degree of apprehension about the second dose of the vaccine. The patient received treatment Tylenol, Motrin, Robaxin for all events. The outcome of the events was recovering. Prior to 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 4 weeks prior to the COVID vaccine. There is no any other medications that the patient received within 2 weeks of vaccination. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Was having trouble, called doctor, went to hospital, diagnosed with blood clots. Given Warphin. Went to out of town. Had heart attack. Went to hospital. Given Estiril. May or may not still have blood clots. Still taking blood thinners. Has upcoming doctors' appointments.
On 3/2/04 evening, pt stated getting rash on side of trunk and behind knees - "little red dots"- raised and surrounded by white areas"  - "3/3/04 evening- rash had spread to thighs, stomach, underarms and chest" rash is itchy. Has had low grade fever since yesterday. No other signs and symptoms.
Post vax, the patient experienced a red area below the injection site the size of a silver dollar. The area was warm to the touch but was not raised. The patient feels fine.
7-20-11 Child woke up with headache and was vomiting. Temp. varied from 101 and 102. Mom took child to Medical Center. Spinal tap/blood work. Treated as bacterial meningitis until results of lab wk. Transported to another Medical Center 7-20-11 at 330p. Discharged 7/22/11 from hosp. Dx with Viral Meningitis.
105.7 fever extremely lethargic, went to ER, was released 6 hours later after getting fever down. Her temperament was extremely off for weeks after, crying for hours on end. She then broke out in a rash over her entire body.
Nausea Headache Chills Fever Vomiting Abdominal pain/cramping  Still with continued headaches and occasional abdominal pain 2-4 times a month
Pfizer BioNTech COVID-19 Vaccine EUA approximately 10 minutes after receiving her second dose, patient report throat tingling and tightness. Later started to have an intermittent cough
Information has been received from a pharmacist concerning a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 22-DEC-2016, the patient received a dose of unexpired ZOSTAVAX (dose, lot # and expiration date were not reported) that was prepared with expired sterile diluent (manufacturer unknown) (lot# L001646, expiration date 20-DEC-2015) subcutaneously for prophylaxis. No known adverse effects. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA014392: US-009507513-1612USA014321: US-009507513-1612USA014391.
After receiving the shot my arm was tad bit red. I felt okay at fine and 1:00am I woke up and my head was hurting terribly. I took Tylenol thinking it would help my headache. I checked my blood pressure and it was 182/118. My eyes were very heavy.  When I got to work I felt so nauseous.
102 fever for 2 days Severe redness, heat, pain and swelling at the injection site for 10 days from shoulder to elbow
I had a severe headache, body aches, exhausted and fatigued.  I had congestion and shortness and breath.  I had to use a nebulizer with Albuterol.  I started taking Advair in the morning and night.  I used the Proventil inhaler as needed.  I started taking the Paxlovid and started feeling good and then two days later I was sick again and tested positive again after previously testing negative.  I had a rebound.  I had extreme fatigue for the next couple months.  It took a long time for me to get my energy back.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients. Medical assistant reported that an unspecified number of patients were administered doses of M-M-R II (lot#, expiration date, dose, frequency, route and indication not reported) from 27-JAN-2014 to 24-FEB-2014 after being exposed to temperatures outside of the prescribing information that were not supported. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
constant ear ache described as "ice picks" that happened as soon as she received vaccine.  Her arm was extremely sore for couple days and eyes felt like she "couldn't open wide enough".
Difficulty in breathing; Swelling of face; Swelling of face and tongue; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Difficulty in breathing), SWELLING FACE (Swelling of face) and SWOLLEN TONGUE (Swelling of face and tongue) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Not sure about the allergy).    On 15-Apr-2021 at 1:52 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021 at 2:22 PM, the patient experienced DYSPNOEA (Difficulty in breathing) (seriousness criteria medically significant and intervention required), SWELLING FACE (Swelling of face) (seriousness criteria medically significant and intervention required) and SWOLLEN TONGUE (Swelling of face and tongue) (seriousness criteria medically significant and intervention required). At the time of the report, DYSPNOEA (Difficulty in breathing), SWELLING FACE (Swelling of face) and SWOLLEN TONGUE (Swelling of face and tongue) outcome was unknown.        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.   EpiPen and 50 mg of Benadryl were given intramuscularly as a treatment for the events. 9-1-1 was called for further evaluation. No information on concomitant medications. 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.
Itchy at injection site; Arm pain at injection site; Rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE PAIN (Arm pain at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE PAIN (Arm pain at injection site). At the time of the report, VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE PAIN (Arm pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; 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