chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered too low / Vaccine may not have been administered into deltoid region, but it was administered further down; Mild cellulitis reaction; Redness at injection site/ Erythematous; Slightly swollen; Edematous; Warm to Touch; This case was reported by a nurse via call center representative and described the occurrence of injection site cellulitis in a adult female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 2277M, expiry date 24th June 2020) for prophylaxis.   On 2nd October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 2nd October 2019, unknown after receiving FluLaval Tetra 2019-2020 season, the patient experienced vaccine administered at inappropriate site. In October 2019, the patient experienced injection site cellulitis, injection site erythema, injection site swelling, injection site edema and injection site warmth. On an unknown date, the outcome of the injection site cellulitis and vaccine administered at inappropriate site were unknown and the outcome of the injection site erythema, injection site swelling, injection site edema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site cellulitis, injection site erythema, injection site swelling, injection site edema and injection site warmth to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the patient was approximately in her 40s, and that the vaccine was administered yesterday in the hospital between 1-3 PM Mountain time. The reporter was registered nurse who reports an employee of the hospital may have had Flulaval vaccine administered too low.  The nurse reports vaccine may not had been administered into deltoid region, but it was administered further down, which led to vaccine administered at inappropriate site. The reporter stated that reaction as mild and described as redness at injection site, slightly swollen, and mild cellulitis reaction approximately 3.5 cm by 4cm. It was erythematous, edematous, and warm to touch. The nurse mentioned reaction resembles several local reactions seen with prior unspecified flu vaccine and it does not appear atypical. The reporter was consented to follow up. This was 1 of the 2 cases reported by same reporter.
My Rheumatoid Arthritis went into a flare starting April 2021 and I am still in a flare. There is inflammation on all my joints and even between joins. It feels more like fibromyalgia with RA. It feels like a ping pong match in my body. One day one area of my body hurts the next another. I am in pain and with inflammation everyday.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On 01-DEC-2017, the patient was administered an improperly stored dose of VAQTA, lot# N019924 with expiration date on 02-SEP-2018 (dose and route of administration were not reported). The administered dose of vaccine underwent a temperature excursion of 47.6 degrees Fahrenheit, which lasted for an unspecified time. There was no previous temperature excursion. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA002258: US-009507513-1712USA008157: US-009507513-1712USA008159: US-009507513-1712USA008160: US-009507513-1712USA008161: US-009507513-1712USA008162:
Upon questioning the patient she indicates that she took 2 doses of her blood pressure medication yesterday.  She did not take it today.  Her blood pressure was low.  She also states that she had some dark stool.  She denies any trauma or injury.  No fevers or chills.  No chest pain or shortness of breath.  No nausea, vomiting or problems with her urine.  On 8/25/2021 that the patient did test positive for Covid.
Pt received vaccine 5/5/16. At site where MMR given, appears warm and swollen (Left upper arm/posterior).
Breakthrough case admission after 2 vaccines Pfizer 4/20/21 Lot# EW0162;  Pfizer 5/11/21 Lot# EW0164
Ringing ears reminiscent of an ear infection, soar throat, fever, chest pains, cold sweats when sleeping, fatigue, congestion
Chills; Headache; Severe sweats; Nausea; Runny nose; Fever; Vomiting; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation.  Medical history included diabetes mellitus.  The patient's concomitant medications were not reported.  The patient experienced positive for covid and negative for the antibodies on 02Feb2021, chills, headache, severe sweats, nausea, runny nose, fever, vomiting on an unspecified date. The outcome of events was unknown.    Information about lot/batch number has been requested.
Headache started about 3 hours afer Flumist nasal vaccine was given to me. The headache then continued on to turn into a full blown migraine (which I normally do not get) and I was up all night tossing and turning in severe head pain.  The next day it lessened and only then had a headache and felt really run down.
Weight loss; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for an unknown indication.    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 WEIGHT DECREASED (Weight loss). At the time of the report, WEIGHT DECREASED (Weight loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) No antibodies from vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
2:10 pm Client verbalized minor throat spasms.  Client was evaluated by onsite paramedics and cleared to go home.
Large erythematous patch from L shoulder to axilla and covering left side of breast. And shoulder and axillary swelling and pain all symptoms develops within 24 hoursof Zojtavax administration.
within 10 minutes of vaccination (administered 11:50 AM) felt weak and tired, became pale and diaphoretic. Pulse weak, irregular. EMS promptly arrive (1 block away) and transported to Emergency Department (within 1 mile). Found to have new onset atrial flutter with rapid ventricular response and BP systolic 86. Improved with diltiazem. Also treated with diphenhydramine and methlyprednisolone
fever; intense headache; This is a spontaneous report from a contactable consumer (patient), or other non-HCP reported for herself. A 61-years-old female patient received second dose of bnt162b2 (BNT162B2; Solution for injection), via an unspecified route of administration and on an unspecified date as dose 2, single for covid-19 immunisation (age at vaccination 61-years-old). The patient medical history and Concomitant medications were not reported. The patient experienced fever and intense headache on an unspecified date. She took Tylenol to manage the symptoms. She mentioned she did not talk to safety yet. Consumer would like to know if she is protected from the COVID19 virus as she would need her hair done 11 days after completing the dose. She mentioned that someone told her that it takes 14 days for someone to be protected after completing the vaccination series. She mentioned that she would be wearing an N95 mask when she does this activity. Response: Affirming to consumer's safety precaution of still wearing N95 mask even after completing the vaccination series." At the time of this report, outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient developed shingles (varicella zoster) around 4/18, two weeks after the vaccine. It is on her head and face.
15mins post vaccination pt reported flushing/sweating, cold sweats, feeling foggy, A&Ox3 Vitals: 14:47 123/67, 65, 18, O2 Sat 100% -- > 121/75, 60, 18, 100% Pt given juice and water Pt stable and released from the vaccination site accompanied by wife @15:10
several hr p/vax pt devel fever to 101 & had episodes of brief shaking spells & screaming;seen in ER on 3OCT96 8PM;swelling of rt thigh;
C/O left upper arm swelling, non tender. 3/4 inch warm area.
38 year old female patient reports after the administration of her first dose she felt a sensation of "latency" in the right eye, pressure in the eye, headache, neck and spinal area. Therefore, she visited her Dr. who indicated "it could have been the effect of the vaccine" so he prescribed anti-inflammatory for the patient. Patient reports the symptoms lasted approximately 4 days.
Second dose given too early, administered after 23 days instead of the earliest allowable 24 days
Information has been received from a licensed practical nurse concerning a 15 year old female patient who was not pregnant. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date in 2015 (reported as "about a year ago"), the patient was vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown). On an unknown date in 2015, about a month following the administration, the patient passed out while she was running. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown) and was well tolerated. On an unknown date in July 2016, the patient was vaccinated with the third dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown). On an unknown date in September 2016, the patient passed out while she was running cross country. So she was rushed to an unspecified emergency room at an unknown hospital where was performed a computerised tomogram (CAT scan) and an electroencephalogram (EEG) to rule out seizures. Unspecified blood tests were also performed (results were pending) and a cardiac monitoring was placed on an unknown date. At reporting time in September 2016, the patient experienced headaches and tingling feeling in her left arm. The patient was not admitted to the unknown hospital, and was discharged from the emergency department on an unknown date in September 2016. At the time of the reporting, the outcome of the events was not reported. The causal relationship between the events and GARDASIL 9 was not provided. Upon internal review, pass out was considered to be medically significant. Additional information has been requested.
The patient describes body aches, chills, fever, and headaches. The temperature was not reported, but fever could be felt "an inch away from the forehead." The patient described sweating profusely and then shaking with chills. Symptoms started approximately 12 hours after vaccine administration and continued into the day following vaccination.
Patient denies any adverse reactions. Patient received 2 dose of Moderna Bivalent( 10/7/22 and 12/28/22).
I began feeling soreness in one of my arms (I had vaccines in both) by the middle of the day, but it felt within the expected reaction. The real reactions that started causing concerns began as very severe chest pain on left side (injection site was upper left arm)  and the pain radiated into the middle of my back from the left side as well. The the chest pain was so bad it felt like I might be having a heart attack. This progressed for a few hours. Following a bath (about 8pm) that was prescribed for another health condition, I began having extreme muscle aches over my whole body (similar to when I had the flu many years ago). My lymph nodes--especially in my groin, were so painful I could hardly move without pain. I also had chills and hot flashes, but no actual fever, I was shaking and felt so ill I could hardly move. I lost my appetite even though I hadn't eaten much that day and had to force myself to drink some water so I wouldn't become dehydrated. Worst was I had such extreme pain on my left side that I had trouble dressing and stayed wrapped in a robe for a while. When I eventually put on a t-shirt the pain was so bad that I felt like I was about to lose control of my bowels and bladder. At some point I did have diarrhea twice that evening.
Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a third dose of GARDASIL vaccine (yeast) 0.5 ml (lot# 0152X). Concomitant therapy included albuterol sulfate (VENTOLIN (albuterol sulfate)), "topical acne medicine" dermatologic (unspecified) and fluticasone propionate (FLOVENT). On 19-JUN-2008 the patient experienced leg edema. The patient was brought to emergency room on 20-JUN-2008 but was not admitted to the hospital. The patient's leg edema persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/15/2008.  Follow-up information was received from a physician concerning the patient developed edema of both lower legs/feet beginning on 19-JUN-2008.  The patient had had a 10-12 pound weight gain since April, 2008.  The physician mentioned in follow up that the patient was still having swelling in the legs and feet.  The patient had seen a cardiologist, gastroenterologist and had had a doppler study and CT of the abdomen.  Additional information has been requested.
pt's arm at injection site became ithcy, red, and swollen. started on 1/6/2021, got worse on 1/7/2021, pt reports its a little bit better 1/8/2021. it is still swollen, not as itchy, not as tender to touch.
!2 hours after 2nd dose of vaccine experienced sudden onset of Headaches, chills, muscle aches, sweats, diaphoretic / pale clammy skin, fever, and joint pain. all the fore mentioned symptoms were not all at once, every half hour and not all once. some symptoms lingered longer than others.
localized erythema and swelling of skin of right thigh, knee area, slightly warm and tense. No redness at immediate injection site, no streaking.  Exaggerated local response to vaccine
diarrhea; covered with hives all over her body; felt really sick; arm started itching; big red patch at the injection site; vomiting; massive headache; tired; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), URTICARIA (covered with hives all over her body), ILLNESS (felt really sick), VACCINATION SITE PRURITUS (arm started itching) and VACCINATION SITE ERYTHEMA (big red patch at the injection site) in a 49-year-old female patient 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 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 FATIGUE (tired) and VACCINATION SITE PAIN (arm pain). On 18-Mar-2021, the patient experienced DIARRHOEA (diarrhea), URTICARIA (covered with hives all over her body), ILLNESS (felt really sick), VACCINATION SITE PRURITUS (arm started itching), VACCINATION SITE ERYTHEMA (big red patch at the injection site), VOMITING (vomiting) and HEADACHE (massive headache). The patient was treated with CETIRIZINE at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Mar-2021, VACCINATION SITE PAIN (arm pain) had resolved. On 23-Mar-2021, DIARRHOEA (diarrhea), URTICARIA (covered with hives all over her body), ILLNESS (felt really sick), VACCINATION SITE PRURITUS (arm started itching), VACCINATION SITE ERYTHEMA (big red patch at the injection site), VOMITING (vomiting), HEADACHE (massive headache) and FATIGUE (tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
This spontaneous report as received from a certified medical assistant (healthcare worker) refers to 7 unspecified patients of unknown age and gender. On unknown dates in 2015 (reported as since 11-MAR-2015), the patients were vaccinated with doses of improperly stored ROTATEQ, oral (dose and lot number were not reported). No adverse effects were reported. Additional information has been requested.
Systemic: Flushed / Sweating-Mild, Additional Details: Pt experienced a brief episode of sweating, after drinking water and eating something he felt fine.
Fever, nausea, diarrhea, itchy Skin/Hives. Joint pain, Myalgia. Trouble Swallowing.
pt recvd vax 20JAN95 & on 23JAN95 stated had t105, throat & neck was swelled-had generalized aching; pt called ER-was told sx caused by vax no need to come to ER; sx subsiding 22JAN95; 23JAN95 neck still a bit swollen;
Child received 3rd dose H1N1 LAIV. mother noted body rash 24hr after vaccination. Clinic site was not notified to not vaccinate child.
When the pharmacist injected the shot, blood spurted out all over my forearm and a bit onto the chair and table I was sitting next to.  Immediately after withdrawing the needle, a large flesh-colored lump had formed on my arm (about a quarter size, raised ~1/2") unlikely anything I've ever experienced when getting a vaccine. The lump had reduced by about half its height after 15min and had dissipated within 2h. Although the lump disappeared, the injection site is bruised and arm very swollen. Symptoms starting ~7h post-injection are as expected (fever (101-102), chills, body aches) and have persisted approx. 20h post-injection.
Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received HAV (Havrix 1440 adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. In October 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The reporter reported that the patient received expired dose of Havrix vaccine. The reporter consented to follow up. Additional supportive information: The patient received Havrix which was already expired, which led to expired vaccine used. This case had been linked with US2022143252 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022143252:Same reporter
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medications details were not reported by the reporter.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date.  Treatment details were not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up document contains no additional information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Pfizer 3/9/21, 3/30/21  (+) on 6/21/22
Sustainted fever greater than 102* for 2 days, with a high of 103.2*; lower back stiffness; rash & raised skin and extreme tenderness at site of injection.
Mom reports that patient vomited at school and was unresponsive. EMS called they did not transport patient to hospital mom went to ED.
ACUTE PULMONARY EMBOLISM 4/12/2023 HTN (HYPERTENSION)
4/24-25 cried all day; 4/26 101-102 temp all day/night; 4/27 101-102 temp all day/night; 4/28 Dr.  sore throat, maybe teething; 4/29 petechia rash; 5/1 appearance of approx 15 bruises; 5/2 Dr, hospital lab; Ph call approx 20 mins, instruc to hospital, platelet decreased 14,000. 10/12/06-DC Summary for DOX 5/2-5/4/06 DC DX: Thrombocytopenia HX of fever to 101 approximately six days prior to admission, had no runny nose, congestion or cough. Seen at PCP office fours days prior to admission DX with pharyngitis and prescribed Amoxicillin. After two doses of Amoxicillin, developed a erythematous papular rash in groin progressed to trunk and then extremities approximately three days prior to admission. Advised to DC Amoxicillin. Patient developed petechia on extremities upper and lower and eventually bruising on lower extremities on day prior to admission. CBC at PCP office platelet count 14,000.  DC on Prevacid.
The vaccine leaked out between the connection of the needle and the syringe.  That connection was found to be loose despite attempting to tighten it.  Several other syringes within that same lot number had the same issues. Approximately 1/3 to 1/2 leaked out.   Moderna was called and advised that at this time, the vaccine recipient should not be revaccinated.
Had GARDASIL and flu shot 10/8/13 came home school headache stiff neck on 10/15/13 -> ER seen 10/18/13 in office stiff neck - given muscle relaxer 10/21/13 follow up with double vision - sent to neuro ophthal increase pressure ocular -> MD - LPC-7 lab MRI (-) D/C home now fine.
The Pediatric dose was drawn up and administered without dilution resulting in a higher than expected dose.  No other information regarding reactions is available at this time.