chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Last vaccine I got nearly killed me / Got sicker than any covid case; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness (serious criteria life threatening). On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated the vaccine nearly killed the patient. After receiving Shingles vaccine, the patient got sicker than any Covid case.
In 24 hours reddened vaccine site. Treatment: BENADRYL TID 1 1/2 tsp by mouth.
l DELTOID REDNESS/SWELLING 5 MM X 4 MM. WARM TO TOUCH
local erythema more sever than expected involving approx 10cm around inj site;placed on ATB for poss cellulitis
inflammation of the sternum; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (inflammation of the sternum) and CHEST PAIN (Chest 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation of the sternum) and CHEST PAIN (Chest pain). At the time of the report, INFLAMMATION (inflammation of the sternum) outcome was unknown and CHEST PAIN (Chest pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment details were provided.  Reportedly, patient's doctor revealed the event of chest pain was unrelated to vaccination and was due to inflammation of the sternum.
During the evening of 9/9/22 I had generalized malaise, muscles aching, etc.  Took Tylenol at bedtime.  About 2 AM, I woke up with a terrible headache, had nausea, and diarrhea started.  I had 8-10 times of diarrhea through out the day.  At noon when I finally made myself get out of bed my temp was 101.1.  I had chills  through out the day as well.  In the evening after taking Tylenol, I felt a little better, but still had a terrible headache.  I would not say I have totally recovered at this point yet at 11:30 PM on 9/10/22.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain for the first couple of days) and LIMB DISCOMFORT (Light discomfort in his upper arm that comes and goes) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (Pain for the first couple of days) and LIMB DISCOMFORT (Light discomfort in his upper arm that comes and goes). The patient was treated with IBUPROFEN at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN (Pain for the first couple of days) and LIMB DISCOMFORT (Light discomfort in his upper arm that comes and goes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Other treatment information included application of Ice.
Patient called pharmacy at 1215pm on 12/23/21 about 1 - 1.5 hrs after receiving vaccine. Was at home and had blurred vision. She stated that she suffers from ocular migraines but was concerned it was a reaction to the vaccine, unsure if it was from her migraine. As we were on the phone, her symptoms started to resolve. No  other reaction, no dizziness, faintness, signs of allergic reaction. We recommended she call her doctor's office for follow up and to call 911 if symptoms progressed before reaching her primary physician.
had mild redness at injection site initially, day 8 post vaccine, woke up with left arm throbbing pain, erythema, difficulty lifting arm secondary to pain. treated with supportive therapy: warm compresses, NSAIDS and is slowly improving. no fever or secondary bacterial infection suspected.  no other flu like symptoms.
a little pain and redness in the injection site that felt warmer than the rest of the arm; a little pain and redness in the injection site that felt warmer than the rest of the arm; a little pain and redness in the injection site that felt warmer than the rest of the arm; This is a spontaneous report from a contactable consumer or other non hcp (From patients daughter). A 84-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a little pain and redness in the injection site that felt warmer than the rest of the arm on an unspecified date. The reporter stated she was looking for this information since she mentions that her mother got recently the vaccine and had a mild reaction to it: she got a little pain and redness in the injection site that felt warmer than the rest of the arm. The patient wanted to know if the pain and redness in the injection site along with the warmness has been reported for Prevnar 13. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Initial unsolicited report received from a consumer (patient's parent) on 13-MAR-2017. This case involves an 11-year-old female patient who was vaccinated with a first dose of MENACTRA (batch number, expiry date, dose and dose in series were not reported) in the right deltoid, a first dose of GARDASIL9 (manufacture: Merck) (batch number, expiry date, dose and dose in series were not reported) and BOOSTRIX (manufacture: GSK) (batch number, expiry date, dose and dose in series were not reported) in the left deltoid on 01-MAR-2017. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as the patient had allergies to eggs, latex, many antibiotics, and had no Medical issues and Illness at the time of vaccination was reported as none. Concomitant medications were reported as none. Any other vaccinations within four weeks of vaccinations were also reported as none. On 07-MAR-2017, six day of following the vaccination, the patient had developed a small rashy spot on the left thumb that eventually over a few days developed on both hands some spots on arms and her chin which raised red not itchy and was warm to touch. The patient required emergency room (ER) or doctor visit on an unknown date. Laboratory investigations were reported as none. Corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Dizziness; Nausea; Vomiting; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (Dizziness), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Jan-2021, the patient experienced DIZZINESS (Dizziness), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) was resolving.        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.  Treatment medications included an unspecified medication for nausea.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
This case was reported by a consumer via call center representative and described the occurrence of faint in a 79-year-old male patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 13th February 2018, less than a day after receiving SHINGRIX, the patient experienced tiredness. On 13th February 2019, the patient experienced pain, shivering and cold. On 14th February 2019, the patient experienced feeling unwell. In February 2019, the patient experienced faint (serious criteria GSK medically significant) and sleep disturbance. On an unknown date, the outcome of the faint, tiredness, pain, shivering, cold and feeling unwell were recovering/resolving and the outcome of the sleep disturbance was unknown. It was unknown if the reporter considered the faint, tiredness, pain, shivering, cold, feeling unwell and sleep disturbance to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on the right arm. At around 2:00 PM, the patient experienced felt tired, achy and started shivering. The patient went to bed at approximately 10:00 PM. The patient would wake up every hour because he had cold. At around 2:30 AM, the patient woke up and felt faint so the patient lay on the floor for four or five minutes. Then, the patient got back into his bed. The patient woke up in the morning but did not feel good. However, at the time of reporting the patient was starting to feel better now. The reporter consented to follow up.
severe allergic reaction; shortness of breath; rapid breathing; asthma; 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 HYPERSENSITIVITY (severe allergic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), RESPIRATORY RATE INCREASED (rapid breathing) and ASTHMA (asthma). At the time of the report, HYPERSENSITIVITY (severe allergic reaction), DYSPNOEA (shortness of breath), RESPIRATORY RATE INCREASED (rapid breathing) and ASTHMA (asthma) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had severe allergic reaction to first dose of vaccine. Patient had shortness of breath and rapid breathing. Patient went to ER and they told patient got asthma and steroids and inhaler were given to patient.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
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 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 18Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 13Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 02Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "borderline high cholesterol" (unspecified if ongoing); "pine nuts" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR]; VITAMIN B12 [CYANOCOBALAMIN]; VITAMIN D3; CALCIUM; TUMS [CALCIUM CARBONATE]; IRON FERROUS SULFATE; MELATONIN; NAPROXEN SODIUM; ALEVE. Past drug history included: Albuterol/ventolin, reaction(s): "Known Allergies: Albuterol/Ventolin"; Albuterol/ventolin, reaction(s): "Known Allergies: Albuterol/Ventolin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
It was reported that a 17 y.o. female PT received a Menomune A/C/Y/W-135 vax, administered SC in her left arm on 9/13/01 at 4:05 p.m. PT was immunized and w/in 20 mins experienced extreme itching. Site was slightly raised and some redness. Benadryl PO was administered. The PT reportedly recovered from this experience.
Vaccine expired on 01-Apr-2022, kept in refrigerator on 04-Apr-2022 and administered on 19-Apr-2022; Received vaccine which expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, kept in refrigerator on 04-Apr-2022 and administered on 19-Apr-2022) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, kept in refrigerator on 04-Apr-2022 and administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine which expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022, kept in refrigerator on 04-Apr-2022 and administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the pharmacy received the vaccine on 23-Feb-2022. The reporter stated that, they thought vaccines will expire in Jun-2022 however vaccines were expired on 01-Apr-2022. The vial did not undergo any temperature excursion.  No treatment medications were reported.
Starting at 5pm on the 12th. Thought I felt heart palpitations. Checked blood pressure / pulse at home BP was 148/88, pulse 94 Rested but no change until 11 pm when BP was 124/80, pulse 76.  No previous experience with this.  Normal BP 120/74, pulse 52.
Localized pain and swelling at injection site expanded along fascial tract of upper arm (L) and eventually into left forearm. Redness and warmth occurred. Achy pain 4/10. Awakened patient every night for the past 3 nights. Slight sensory changes (numbness) and occasional paresthesias down to hand. Strength WNL. Cap refill < 2 seconds. ROM affected/limited by swelling.
2 patients received the booster after 12 hours of puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients received the booster after 12 hours of puncture) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 040A21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received the booster after 12 hours of puncture). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (2 patients received the booster after 12 hours of puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is taking other medication. No concomitant drugs were reported. No treatment drugs were reported.
Pt felt weakness in lower limbs and dizziness. Pt. taken to ER.
itchy welts appeared on legs and ankles. Patient applied Calamine and the welts disappeared temporarily, for maybe 3 or 4 hours. Still having symptoms as of 9/1/20. When patient took Claritin today the symptoms subsided
Tachycardia severe shortness of breath Narrative:  Per employee "onset of symptoms 3/5/21 what symptoms severe shortness of breath, tachycardia medications needed, Albuteral inhaler, SVN treatments, Spiriva Inhalers, Budesonide inhaler, Montelukast history of any vaccine reactions: NEVER any vaccines within the preceding month No, I had Covid in September 2020 and asked for a antibodies test prior to the first shot, I was told no, that it was not "medically indicated" requested but not required, chronic medical conditions. NONE PRIOR TO THIS SHOT" No admission however had to be seen by and currently followed by pcm, cardiologist, and pulmonologist as symptoms are "worse". also subsequently placed on two medications for new onset hypertension.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 07-Mar-2021 and the estimated date of delivery was 19-Dec-2021. On 26-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 26-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient talked to her primary care physicians who recommended delaying the second dose of the vaccine until the second trimester of the Pregnancy . Concomitant medications were not provided. Treatment information was not provided.
Vial which was expired on 3Apr2022 was administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial which was expired on 3Apr2022 was administered to patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 EXPIRED PRODUCT ADMINISTERED (Vial which was expired on 3Apr2022 was administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial which was expired on 3Apr2022 was administered to patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was provided by the reporter.  Expired vaccine was administered to total of 24 patients including 15 males and 9 females. It was reported administrations were mostly for booster shots. No side effects were reported for the patient.  No treatment information was provided by the reporter.
Patient's left arm became extremely hot, red and swollen. The area of redness was 4 inches in diameter. She had pain from her wrist to her shoulder. She did not feel well.
Small and localize  Right Axillary adenopathy ,with a little of pain in the area
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 50-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient had tested positive or diagnosed with COVID-19 previously.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medications were reported.  Vial size was reported as 10 dose vials. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions.  It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not have any details on that event at the time of report.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Patient experienced severe chills and muscle cramps, low grade fever the night of the shots. Subsided by next day.
I was positive for COVID-19 pn 19MAR2023, I had fever and chills headache and a respiratory congestion. My blood levels were low, I went to the emergency room and they gave me paxlovid that was regulated for me because of my liver issues. They were concerned because my oxygen has been abnormal.