chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 09-Nov-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
Breakthrough COVID-19 infection. Symptoms: fatigue, aches, sore throat, cough, congestion, occasional shortness of breath. Tested positive on a rapid antigen test on 12/27/2022.
Had both doses no energy; Food has no taste; Taste like perfume; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "Had both doses no energy"; AGEUSIA (non-serious), outcome "unknown", described as "Food has no taste"; TASTE DISORDER (non-serious), outcome "unknown", described as "Taste like perfume".  Additional information: The patient was to receive booster that day with a friend.  She states she was feeling under the weather and asking if she should take it? She states she has had both doses no energy for the past few weeks. Food has no taste. Taste like perfume.    The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Shortness of breath, dizziness & abdominal pain began 5 hrs after vaccine administration. Pt had decreased peak flow & afebrile. Still ill on 2/2 but improving.
10:30am on the 28th of March while at work I suddenly felt a bit dizzy and disoriented.  Head began to feel like a pressure headache. Could not focus or concentrate at all.  Had to call for someone to drive me home as I did not want to drive. Now ( 24 hours later ) I still feel the same. Slight headache but more concerned with lack of being able to  concentrate.  Knowingly making little mistakes  when  trying to function.  Not confused but can not think clear or focus on what I'm doing
Pt was dizzy became nausea, and developed a headache. BP was163/105. She was obcerved for almost an hour and then had dry heaves. She was sent to Er for further treatment and observation
Patient received Jynneos, MenQuadfi, and Gardasil on July 21, 2023. MenQuadfi and Gardasil was administered both on right deltoid. Patient denies on any reaction for Menquadfi and Gardasil. Jynneos was administered on left arm, subcutaneous route. After two days, patient noticed a itchiness and big red rash on the left arm, on which the Jynneos was given. Patient noticed the reaction while at amusement park around 0900, patient continued about his day and when shower on Jul 24 after showering the area had increased. The rash measurement is 10cm. Then proceeded to work and was seen my his primary care provider which directed him take a Benadryl to go back to the clinic to get checked.
At the injection site, there was raised area of redness and itching and it looked like it was macular, papular in detail; At the injection site, there is and 8x3 raised area of redness and itching; At the injection site, there is and 8x3 raised area of redness and itching; Jynneos vaccine administered intradermally; Case reference number US-BN-2022-001908 is a spontaneous case report initially received from a nurse practitioner via agency (reference number: USBAV22-1013) on 16-Aug-2022 and concerns an adult male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.   On an unknown date, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided) at an unknown dose or site of administration, intradermally, for unknown indication (explicitly coded as 'inappropriate route of vaccination').    On an unknown date, also reported as within 24 hours after the Jynneos vaccine, the patient had a reaction to the Jynneos injection, at the injection site, there was an 8x3 cm raised area of redness and itching and it looked like it was macular, popular in detail.   At the time of this report, the patient was recovering from all events.  The reporter did not provide seriousness and causality assessment for reported events.  Additional information received from Bavarian Nordic on 16-Aug-2022 included local BN case ID.; Reporter's Comments: An adult male patient of an unknown age developed non-serious events injection site redness, injection site pruritus and maculopapular rash 24 hours after Jynneos was administered intradermally, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. Maculopapular rash is unlisted, while injection site pruritus and injection site redness are listed per  agency 1 and the agency 2. The patient's concomitant medications and medical history were not reported. Considering plausible temporal relationship, maculopapular rash, injection site pruritus and injection site redness have been considered as related to Jynneos. Inappropriate route of vaccination is not related to Jynneos, but to a human factor.; Sender's Comments: An adult male patient of an unknown age developed non-serious events injection site redness, injection site pruritus and maculopapular rash 24 hours after Jynneos was administered intradermally, which is considered inappropriate route of vaccination. Inappropriate route of vaccination is listed by convention. Maculopapular rash is unlisted, while injection site pruritus and injection site redness are listed per agency 1 and the agency 2. The patient's concomitant medications and medical history were not reported. Considering plausible temporal relationship, maculopapular rash, injection site pruritus and injection site redness have been considered as related to Jynneos. Inappropriate route of vaccination is not related to Jynneos, but to a human factor.
Shingrix already expired was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a adult patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 28th February 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The patient received expired Shingrix vaccine. The reporter did not have data form the patient or exact date from vaccination, accurate data about lot number, but knew that Vaccine had expiration date for Feb/2021. This case has been linked with US2021094214, reported by same rporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094214:Same reporter.
Left deltoid with swelling, redness, hot. Pt c/o pain to site Rx Keflex 500 mg QID x 7 days.
Associate received the Pfizer booster shot on 9/24/21 and on 9/25/21 she began to experience symptoms of chills, headache, body ache, and a fever of 99.0 degrees F. She also experienced pain at the injection site.
01/20/14 pt presents with reaction on (L) thigh red upraised, itchy welt. It is in the same place as where she got Dtap on 01/17/14 during her 18 month check-up (4 cm diameter upraised pink round lesion on (L) UT.
She has nasal congestion, cough, headaches, sinus pain, congestion. By afternoon she developed body aches and loss of smell. She has a tight chest, and mild shortness of breath-history of mild intermttent asthma, and inhalers are expired.  symptoms starting 11/25/21
I am currently 21 weeks pregnant. is due July 24th, 2021. This is my first pregnancy and I?ve had no complications. NIPT results indicated no sign of issues. My 20 weeks ultrasound right after my first dose of the Pfizer vax went fine.  I developed a rash on my chest days later. 9 days after receiving the vaccine. This is the first time this has ever happened to me. The rash on my chest is red, burning, and itching and has been there for 3 days now.
chills; body temperature; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (body temperature) and PAIN (body aches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), PYREXIA (body temperature) and PAIN (body aches). At the time of the report, CHILLS (chills), PYREXIA (body temperature) and PAIN (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications are provided. No treatment.
02/02/22 presents to ED for "AMS and recurrent falls". PMHx of "ETOH abuse, ETOH withdrawal with seizures, bipolar disorder, DVT on Xarelto, and suspected COPD"
The patient's daughter called and said that her mother broke out with rashes all over her body one day after receiving flu shot. I advised her to take her mum to ER
Red, swollen, itches, seems to have a knot, placing ice packs, extremely tired, headaches, lethargic, sick to stomach been going on a week
7 days after initial IM injection--pain, pruritus, redness and warmth of left deltoid. Area felt indurated on palpation. Resolved after 2 days. Highly localized to injection site.
Itchy, bumpy, red rash. Rash started on my left hip, side of my thigh, about the size of two dollar bills side by side, long ways. Rash spread in small dots to my left forearm, torso, chest, neck.
INCORRECTLY STORED VACCINE INJECTED; VACCINE STORED IN SYRINGES AT ROOM TEMPERATURE FOR 3 HOURS INSTEAD OF 2 HOURS; This spontaneous report received from a pharmacist concerned a 58 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUN-2021, the subject experienced incorrectly stored vaccine injected. On 08-JUN-2021, the subject experienced vaccine stored in syringes at room temperature for 3 hours instead of 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrectly stored vaccine injected and vaccine stored in syringes at room temperature for 3 hours instead of 2 hours was not reported. This report was non-serious.
Started with a 100.4 fever, then crabiness, rapid breathing, coughy/vomiting sounds. She then spiked 101 fever by 315 then by 430 she spiked to 103. She was taking back to the doctor and treated with Tylenol at 515. The fever continued till approx 730 pm, and returned at 920pm at 101 then by 945 it was 103 again.
New flare of autoimmune disease (multiple sclerosis). Treated with multiple steroid infusions
there was a bulge; Underdose / patient received about half the product; there was a bulge, so it was not in the muscle; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number AP257, expiry date 26th November 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site swelling, accidental underdose and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site swelling, accidental underdose and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The pharmacist on the line stated while administering the product, the patient looked like she was surprised and moved away so the needle came out. Some of it came out and there was a bulge, so it was not in the muscle, which led to intramuscular formulation administered by other route. The patient received about half the product, which led to accidental underdose. The reporter gave permission to follow up. This case had been linked to the case US2019143920, reported for same patient.
Enlarged Right tonsil, fever of 102.9, sore throat, congestion, headache, belly ache Treated with Augmentin and Dexamethasone All other symptoms have improved except right tonsil is still enlarged
Case number PHHY2011US33870 is a combined initial and follow-up spontaneous report received from a health care professional (HCP) on 19 Apr 2011. This report concerns a 15-year-old female patient. Her medical history was not reported. She was vaccinated with MENVEO (batch number: 100003, expiry date: Aug 2011) 0.5 ml dose, intramuscularly on 18 Apr 2011 which was stored incorrectly at a temperature of 55 F, one hour every night for one month. No adverse event was reported.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 27-MAY-2016, the patient was vaccinated with improperly stored VARIVAX lot # L043622, expiry date 03-NOV-2017 (dose, route and site of administration were not reported) and M-M-R II, albumin status recombinant human albumin (rHA), lot # L027434, expiry date 22-JUL-2017 (dose, route and site of administration were not reported) which was also improperly stored. There were no adverse effects reported. Administered vaccines experienced following temperature excursions: on 14-MAY-2016 6 degrees Fahrenheit (F) for 1.5 hours and on 20-MAY-2016 5.9 degrees F for 5.5 hours. The freezer returned to proper range in between all excursions. Data logger was involved. This is one of several cases received from the same source. Additional information has been requested.
tested positive for covid; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   Concomitant medication details were not provided by the reporter.  On 05 Aug 2021, patient received antibodies treatment. He is due for the second dose of the vaccine.
Lump underneath his arm, Lump started to get bigger in the last few days; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Lump underneath his arm, Lump started to get bigger in the last few days) 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 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced AXILLARY MASS (Lump underneath his arm, Lump started to get bigger in the last few days). At the time of the report, AXILLARY MASS (Lump underneath his arm, Lump started to get bigger in the last few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter   This case was linked to MOD-2021-381136 (Patient Link).
pt recvd vax & was pale, limp; blueness of lips & angioma of nose; MD called & diaphoresis noted;
C/o worsening facial irritation along with rash since last Fri. couldn't sleep due to itching and pain. states has very sensitive skin. took Benadryl on Fri and Sat but not helped. COVID vaccinated on 28 Dec 2020. denies sob or difficulty to breath
Immediately after my injection, I had severe muscle soreness and limited ability to move my arm. This worsen over the course of 2 days and stopped by day 5. On day 3 I started noticing mild headaches constantly throughout the day and weakness in both forearms and hands. These would worsen as time went on.  At the 2 week mark, I noticed more varying joint pain, stiffness, and mild paresthesia in my hands and feet. I saw my PCP and she recommended not to continue with the 2nd shot as I am having side effects. Currently taking aspirin 81mg, vitamin D and C as recommended by my doctor. Symptoms still persist 3 weeks after my injection.
Approx 10 min generalized tonic clonic sz /w cyanosis.T 100.8, Erythema lt thigh.Subsequently had 2 additional sz while hospitalized-began on Phenobarbital.
Pt received Pfizer Vaccines in March of 2021. Pt presented to the ED on 11/03/21 with complaints of a cough. Pt was found to be COVID positive and was discharged home on 11/03/21. Pt presented to the ED on 11/10/21 after a fall. CXR showed COVID pneumonia and pt was requiring supplemental oxygen during admission.
Mortality of fully vaccinated patient Patient presented on 11/20/2021 with complaints of weakness and dyspnea after being diagnosed with COVID-19 on 11/16.  She had been being treated as an outpatient with supplemental oxygen and dexamethasone.   She was also being treated for urinary tract infection.  supplemental oxygen requirements in the ED were  only 4-5 L nasal cannula however upon admission and transfer to the CCU oxygen requirements went up to 15 L high-flow with variable saturations in the mid 80s to mid 90s.  Due to this rapid change in O2 requirements the patient was then a candidate for additional COVID-19 treatments under the experimental protocols.  After discussing the risks and benefits with the patient she requested to proceed with treatment using baricitinib and remdesivir.   Initial hypoxia  prior to presentation resulted in a type 2 MI,  cardiology was consulted,  and echocardiogram was obtained.  Repeat echocardiogram performed 3 days later showed significant improvement and resolution of initial injury.   Over the next couple days the patient's oxygen requirements continued to increase and she was begun on Airvo and then BiPAP.   The patient declined intubation upon presentation should that become necessary.  The patient tired of the BiPAP and requested for us to call her children to come in and make a family decision regarding the next steps in her care.   Patient and family agreed to go comfort measures,  the family gathered around and the patient was taken off of supplemental oxygen,  and passed peacefully.
COVID-19; COVID-19; This is a solicited report based on the information received by Pfizer from Regulatory Authority (Mfr. Control No.: 21K-163-4054062-00).   This is a solicited report from the USA by a contactable consumer (patient) of an adult female with an event of non-serious COVID-19 with upadacitinib. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 vaccination; upadacitinib (RINVOQ), orally from an unspecified date (batch/Lot number was not reported) at unspecified dose for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. It was unknown if the patient was enrolled in a COVID-19 vaccine trial. On unknown date, she received COVID-19 Vaccine manufactured by Pfizer. On an unknown date, the patient experienced COVID-19. Pfizer Biontech Covid-19 Vaccine  was also considered suspect. The action taken in response to the event for upadacitinib was unknown. Outcome of COVID-19 was unknown.   Causality for upadacitinib: the reporter's causality for the event of COVID-19 was not provided. Causality for bnt162b2: the reporter's causality for the event of COVID-19 was possible.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events DI and Covid 19 and suspect drug BNT162B2 cannot be excluded
Nausea, "wobbly, shaky" chills; onset 6 pm on day of vaccine - present.
"got her period 2 weeks early" and reports it was "heavy"; "got her period 2 weeks early" and reports it was "heavy"; Sore arm; eyelid and face itching and burning; eyelid and face itching and burning; eyelid and face itching and burning; eyelid and face itching and burning; This is a spontaneous report from a contactable consumer(patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number unknown), via an unspecified route of administration on 05Jul2021 (age at vaccination 35 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she was fine, except for a sore arm and on the next day of vaccination, she got her menstrual period 2 weeks early, and it was a heavy flow on 06Jul2021, she also experienced eyelid and face itching and burning. The outcome of events was unknown.  Information about lot/batch number has been requested.
C/o itch, erythema, itching starting 2 days after anthrax #2. A: local reaction. P: Tylenol, Benadryl - 7/U PRN
Father noticed warm, red, swollen left upper arm, however there was no pain or limitation of motion in the left shoulder and the elbow. No fever, no trauma history.