chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Expired dose of the Moderna Covid-19 vaccine was administered to 1 patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose of the Moderna Covid-19 vaccine was administered to 1 patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose of the Moderna Covid-19 vaccine was administered to 1 patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose of the Moderna Covid-19 vaccine was administered to 1 patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired dose of the Moderna Covid-19 vaccine was administered to 1 patient).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  Treatment medications were not provided.   Reporter did not allow further contact
This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (It then moved toward her breast. It has moved beyond her breast. She has swelling from the bottom of her breast through her belly), ABDOMINAL DISTENSION (She has swelling from the bottom of her breast through her belly), PAIN (She has states it was sore), VACCINATION SITE MASS (At the shot site there was an area half the size of a lacrosse ball on her arm) and AXILLARY MASS (She states it moved to underneath her arm/She states it feels like jelly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H213) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Had no reaction.) in April 2021 and Pfizer (Had no reaction.) in May 2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer.    On 05-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST SWELLING (It then moved toward her breast. It has moved beyond her breast. She has swelling from the bottom of her breast through her belly), ABDOMINAL DISTENSION (She has swelling from the bottom of her breast through her belly), PAIN (She has states it was sore), VACCINATION SITE MASS (At the shot site there was an area half the size of a lacrosse ball on her arm), AXILLARY MASS (She states it moved to underneath her arm/She states it feels like jelly) and LYMPHADENOPATHY (She had swelling underneath her arm). At the time of the report, BREAST SWELLING (It then moved toward her breast. It has moved beyond her breast. She has swelling from the bottom of her breast through her belly), ABDOMINAL DISTENSION (She has swelling from the bottom of her breast through her belly), PAIN (She has states it was sore), VACCINATION SITE MASS (At the shot site there was an area half the size of a lacrosse ball on her arm), AXILLARY MASS (She states it moved to underneath her arm/She states it feels like jelly) and LYMPHADENOPATHY (She had swelling underneath her arm) outcome was unknown.            No Concomitant medication information was reported.  No Treatment medications were provided  It was reported that she had been to the doctor and they have told her they are all normal.   Reporter did not allow further contact
First dose was Pfizer vaccine; unavailable for 2nd dose in series-Moderna administered.
Redness, swelling, hot to the touch, leg pains. Told it?s normal by the physician in urgent care and to give Tylenol/ibuprofen. Still ongoing symptoms.
Shot given at approximately 12:00 noon. At 2 pm noticed very dry mouth, harder to swallow, felt a little swollen, mild panic feeling. No swelling, dizziness or hives. Lasted 3 1/2 hours until 5:30 pm.
This spontaneous report has been received from a medical assistant referring to a 16 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. In 2017 (reported as someday during 31-JUL-2017 to 22-AUG-2017), the patient was vaccinated with GARDASIL 9 lot # N000326 / N002720, expiration date 14-OCT-2019 (dose and route unknown) for prophylaxis. The vaccine was exposed to temperature excursion of 34.6 degree Fahrenheit (F) to 34.9 F for 255 hours from 31-JUL-2017 to 22-AUG-2017. Data logger involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010748.
I gave her a covid shot, and about 5 minutes later she fainted while sitting in the chair. We rushed out there and she was i the floor in the booth. Sh e came to as we lifeted her up. Was very pale and clamy. No medical conditions or allergies. Thought she was goimg to vomit, but never did. Sh ethen fainted again while we were there with her, and came to within just a few seconds. We called 911 and amblance came and took her to the hsopital.
LUA- 4cm bluish/red area surrounded by 2cm halo of erythemic plaques
IM injection given, small amount vaccine liquid on arm after injection.  More than half vaccine administered.  Dose not repeated.
This is a spontaneous report from a contactable healthcare professional, reporting on behalf of a physician. A female patient of an unspecified age and ethnicity received the first dose of PREVNAR13, intramuscular on 15OCT2014 at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date in OCT2014, the patient experienced not feeling right, not feeling well since, felt sick, felt very  heavy, she could not move her body, had to stay in bed, needed help to get around, limp, no energy to do anything, hadn't been herself, fatigue and loss of appetite. The clinical outcome of the reported events was unknown. It was reported that the  patient wanted to know if the events could be side effects of PREVNAR13. Follow-up (27OCT2014): new information received from the contactable healthcare professional includes: reaction data (added event: could not move her body). Follow-up (20OCT2014): New information received from the same contactable healthcare professional on behalf of a physician via a sales representative includes: suspect product data (changed from PREVNAR to PREVNAR13, and reaction date (added events: fatigue and loss of appetite). Follow-up (16DEC2014): Follow-up attempts completed. No further information expected.
Sore arm at the vaccination site; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm at the vaccination site) and FATIGUE (Tiredness) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the vaccination site) and FATIGUE (Tiredness). On 28-Mar-2021, VACCINATION SITE PAIN (Sore arm at the vaccination site) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided   This case was linked to MOD-2021-207780 (Patient Link).
Patient was fine immediately after vaccination. She left our vaccination room to sit down and wait 15 minutes and for some reason did not sit down, but kept walking, then proceeded to lay herself down in an aisle of the store. She says she passed out. I only witnessed her being awake. She urinated herself. She asked for a pillow and cold wash cloth. We got her those. We tried to get her a snack and a juice, but she didn't take those. I had a technician call an ambulance and pressed a button we have that calls the police as well. The police arrived first. The ambulance crew took her out into their truck to be evaluated and said she was fine, but had her mom come pick her up because they just didn't want her to drive. She did tell me before I gave her the shot that she passes out from vaccines.
I was having a headache with a scratchy throat along with a cough. I was generally just not feeling well. I ended up taking a COVID-19 Home Test which was negative. The next day I was still feeling poorly so I took another test and it was also negative. I still just felt horrible so I went to the doctor and they did a COVID-19 PCR Test and it was positive. I had gotten worse by this point and just was feeling so bad along with having developed a slight fever. My doctor gave me some cough syrup and some nose spray.
Child is 13 years of age. Child received Pfizer COVID vaccine for age group 5 yrs through 11 yrs.
An hour later of administration of the vaccine Pt called the pharmacy complaining of numbness and tingling sensation.  From the talk to Doctor at office to report her S.E
After first shot, body aches, hot/cold flashes, feeling I?ll, eczema patches (6 dime size patches). After second shot I had roughly 15-20 more patches in addition to body aches, headache, and hot/cold flashes.
12/1/08 @ 2:30pm TDAP vaccine administered.  Client returned to clinic on 12/3/08.  Related a minor sore arm on 12/2, and then on 12/3 early am developed a 2" area at vaccine site that was red and slightly tender.  By 10am on 12/3/08 the area of redness had increased, was warm, and was increasing in size.  At 11:30am in clinic the area was noted to be red, tender and warm to touch, and approx. 4" X 3 1/2".  Appeared to be spreading toward elbow area.  Clients temp was 98 degree and she had no other complaints.  No history of previous allergies or vaccine reactions.  Dr. was contacted and prescribed Augmentin 1000 mg QD X 7 days with a recheck of vaccine site on 12/4/08, and ER visit if S&S of respiratory distress or progression of rash or swelling.  Return to clinic 12/4.  Reaction site was improved.  measured 4X 5 1/2 inches with decreased redness an induration.  Client states that swelling extended from shoulder to elbow last PM before starting Augmentin.
Sore right arm still and getting worse. She is going to speak with her dr. Hoped it would go away. Just told me/us today 07/06/2017.
bicep soreness (same day), headache (next day), upset stomach (night of and next day)
Patient developed small bumps along her left jaw line. Patient did not have swelling of the throat or any difficulty breathing. The patient was treated with 50mg of Benadryl tablets, and sat for observation. Her husband was able to drive her home without any further progression of symptoms. Advised patient to call 911 or go to ER if symptoms progressed, and I assured her that I would follow up with her again in the morning.
Fever, nausea, vomiting, diarrhea, headache, myalgias, fatigue and malaise for 72 hours. Followed by severe asthenia, headache and nausea with anorexia for next 5 days. Currently persistent generalized weakness unable to exercise
Patient with single J+J COVID vaccination who admitted to hospital with COVID detected PCR and complications from COVID.  Provider d/c note:  "Reason for Admission: Generalized body pain, no weakness 60-year-old female patient with past medical history of bipolar, coronary artery disease, hypertension, hyperlipidemia, paroxysmal AFib, T IA morning (8/12/2022) has had generalized body constant cramps, shortness of breath even at rest, chills but not a fever, a slight non-productive cough, intermittent, non-radiating squeezing discomfort left anterior chest with intensity of 3 or 4 on 0-10 scale for which she got some relief with Tylenol, nausea, vomiting (x 3-4 times) and diarrhea (x 6-7 episodes).  Energy level has been ""crappy"" and felt like she was going to pass out several times.      Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures)  treated for COVID pneumonia, with acute hypoxic respiratory insufficiency,  Significant improvement in oxygenation, off nasal cannula oxygen ? Pneumonia due to COVID-19 virus with acute respiratory insufficiency with hypoxemia - oxygen per protocol; Decadron, has added Remdisvir , CTA pulmonary negative for pulmonary embolism, CT chest showed bilateral ground-glass opacities consistent with COVID"
This initial spontaneous report was from a registered nurse, concerning a patient of unknown age and gender. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described. The reporter stated that on 06-JUL-2016; the patient was administered one dose of VARIVAX injection (dose, route and anatomical location were not reported); which was improperly stored. The dose was from one of the following lot numbers: L045956 with expiration date 17-NOV-2017, M00757 with expiration date 06-JAN-2018, L046885 with expiration date 23-NOV-2017 or L034369 with expiration date 08-SEP-2017. The excursion was due to a data logger: and the outcome of the excursion was reported as "supported until labeled expiry". There was not any previous excursion. It was also reported that no doses were administered. No adverse effects were reported and product quality complaint (PQC) was not involved. It was unknown if the patient sought medical attention. Additional information has been requested.
Suspected vaccination failure/had the shot and still got the shingles; shingles/had the shot and still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-June-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient had the shot and still got the shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
On Mar 20, 2002, the pt rec'd his 2nd injection of Engerix-B. On 3/22/02, the pt experienced experienced joint pain, headache, tiredness, muscle aches, and nasal congestion. Treatment was not provided. The pt reported that he "coped" with the discomfort and that all events resolved in 3 weeks. The reporting person did not specify the relationship between the Engerix-B administration and join pain, headache, tiredness, muscle aches and nasal congestion.
swollen rt deltoid, red, warm to touch; stiffness w/sl pain; sxs lasted 7 days;
red round circle size of a fifty cent piece also a sl itch lasted 2 days;caused by the pneumonia vax placed in rt arm;
SWOLLEN FACE; VERY RED FACE; TYPICAL SIDE EFFECTS; CHILLS; BIT OF NAUSEA; INJECTION SITE VERY SORE; HEADACHES; This spontaneous report received from a consumer concerned a 50 year old female. 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: 1822809, expiry: UNKNOWN) dose was not reported, administered on 19-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-OCT-2021, the patient experienced swollen face. On 19-OCT-2021, the patient experienced very red face. On 19-OCT-2021, the patient experienced typical side effects. On 19-OCT-2021, the patient experienced chills. On 19-OCT-2021, the patient experienced bit of nausea. On 19-OCT-2021, the patient experienced injection site very sore. On 19-OCT-2021, the patient experienced headaches. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bit of nausea, injection site very sore, chills, headaches, swollen face, and very red face, and the outcome of typical side effects was not reported. This report was non-serious.
patient experienced dizziness, broke out in a cold sweat HR dropped to 31, o2 sat dropped to 92 and patient became pale. At this time the patient was laid back in seat and given water to drink cold wash cloth. I continued to talk with him and reassure him while monitoring his vitals to make sure they were coming up. After a couple of minutes the patient was feeling better and HR was 72 and o2 sat was 99 we continued to monitor another 30 minutes.
tested positive on 09FEB2021; tested positive on 09FEB2021; This is a spontaneous report.  A 77-year-old unspecified gender patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number unknown, Expiration date unknown), via an unspecified route of administration, on 26Jan2021, at single dose for Covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient tested positive on 09Feb2021. The outcome of event was unknown.  Information about lot/batch number requested.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021, and tested positive on 09Feb2021.  No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information needed for a full meaningful medical assessment.
Thyroiditis: inflammation of thyroid; Pain swallowing; Sweating; Fatigue; Nausea; Elevated creative protein; Elevated ESR Rate; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received second dose bnt162b2 (Pfizer COVID 19 vaccine), (lot number unknown, Unable to locate or read the details), via an unspecified route of administration, administered in Arm Left on 03Feb2021 13:15 as single dose for COVID-19 immunisation. Medical history included known allergies to Sulfa and High blood pressure. The patient was not pregnant. Concomitant medications in two weeks included rosuvastatin calcium (CRESTOR); valsartan; ezetimibe (ZETIA); hydrochlorothiazide (HCTZ); colesevelam hydrochloride (WELCHOL) ; ergocalciferol (VITAMIN D); all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (Pfizer COVID 19 vaccine), via an unspecified route of administration, administered in Arm Left on 13Jan2021 15:45 as single dose for COVID-19 immunization.  The patient did not receive other vaccine in four weeks. The patient experienced thyroiditis: inflammation of thyroid, pain swallowing, sweating, fatigue, Nausea, elevated creative protein: went from 0.4 to 14 Elevated ESR Rate on 04Feb2021 01:00 PM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the events included 400 mg of Motrin every 6-8 hours. The patient did not have covid prior vaccination. The patient had COVID tested post vaccination, test type post vaccination was Nasal Swab on 26Feb2021 with results Negative. Facility type vaccine was Nursing Home/Senior Living Facility. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Case completed primary Covid vaccine in April 2021, then died of Covid in May 2022. Hospitalized at Medical Center. Was admitted to hospital with Change in mental status, fevers and exacerbation of COPD. She progressively grew more ill, and died in hospital after 3 days of care.
positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer reported that a male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient has gotten really sick and tested positive for COVID-19 on unspecified date in 2021. Outcome of the event was unknown.  Information about Lot/Batch has been requested.
Erythema, tiredness 2 hrs after the injection. Shortness of breath off and on over 2 hours - Comment: Rule out SOB due to physical exertion and/or anxiety.
Fever 101-102 degrees F; associated with poor sleep.  Jitterness and tongue fasiculations occational sudden arm and leg movements syptoms resolved within 48 hrs.
within 3 hours, intense pain at site of injection, lasted 2 days within 6 hours, insomnia - fitful, interrupted sleep throughout the night beginning at about 12-15 hours post-vaccine, headache, extreme fatigue, nausea, chills, vomiting, subsided for several hours and returned by 20 hours post-vaccine - extreme fatigue, chills, fever by 30 hours post-vaccine all symptoms other than sore arm subsided
A 9-year-old female developed fever, injection site pain and nausea during RabAvert dosing. On 25 August 03, the subject received her fourth 1 mL dose of RabAvert, intramuscularly. While traveling on vacation, the family packed the fourth dose of RabAvert without maintaining the medication in the proper temperature range. It was reported the vaccine felt "cool". She developed a fever of 102 degrees F, pain at the injection site and nausea the evening after the fourth dose was administered. No rash, hives or sore throat were noted.  Follow up received 09 Sep 03: The patient received the third dose of RabAvert on 25 Aug 03, not the fourth as previously stated. RabAvert was given due potential exposure to a bat. She developed the fever of 102 F the afternoon of 25 Aug 03. The next morning, the patient awoke with a fever of 101.5 F. Soreness at the injection site was noted. The patient's parents stated the vaccine had remained unrefrigerated for six hours. She has made a complete recovery from the events.   Follow-up received 09 Sep 03: The patient received the third dose of RabAvert on 25 Aug 03, not the fourth as previously stated. RabAvert was given due potential exposure to a bat. She developed a fever of 102 F the afternoon of 25 Aug 03. The next morning, the patient awoke with a fever of 101.5 F. Soreness at the injection site was noted. The patient's parents stated the vaccine had remained unrefrigerated for six hours. She has made a complete recovery from the events.