chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30 male patient received an expired pediatric dose of ENGERIX-B; expired pediatric dose of ENGERIX-B; 30 male patient received an expired pediatric dose of ENGERIX-B; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 30-year-old male patient who received HBV (Engerix B pediatric) (batch number AN3NC, expiry date 3rd June 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th September 2021, the patient received Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 20th September 2021, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose, expired vaccine used and adult use of a child product. On an unknown date, the outcome of the underdose, expired vaccine used and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Pharmacist reported that a 30 year old male patient received pediatric dose of Engerix B on the 20th September 2021, which got expired on 3rd June 2021, which led to expired vaccine used, adult use of a child product and underdose. No further details were provided at the time of the call. The reporter consented to follow up by email.
After receiving the Moderna booster shot vaccine in November of 2021 I developed the classic flu like symptoms and then I recovered and felt fine. However in mid August 2022 I suddenly lost my sense of taste and smell without accompanying illness. I tested negative for COVID. Eventually my sense of smell and taste started to come back.  Then I caught a cold and lost my sense of taste and smell again. Again I tested negative for COVID. Now every time I get a mild cold I am losing my sense of taste and smell. I?m 48 years old and prior to being vaccinated I hadn?t been sick with any colds or flus for about 2 years. The last time I recall being sick with a bad cold and losing my sense of taste or smell and having distorted taste was when I was about 8/ 9 years old. Since that age I haven?t had any issues with my smell or taste no matter how severe my nose was congested or my throat sore, etc. My ongoing loss of taste and smell seems like it may be related to the COVID vaccine since I have never actually tested positive for COVID despite numerous testing for the illness based on my loss of smell and taste. I suspect that the vaccine is causing by body to have an inflammatory immune response  every time I get sick and even when I?m not sick or asymptomatic. Also?please note that around the time of my first loss of smell and taste I had a Lupron -Depot injection to treat adenomyosis of the uterus to prepare for an FET cycle.  At first I thought my loss of taste and smell may be related to the Lupron, but since I?m losing my smell and taste every time I get sick with a cold I am wondering if my loss of smell and taste is related to the vaccine? I took Lupron Depot in 2019 before getting pregnant with my son who was born in May 2020. I didn?t have any side effects from the treatment.
No issues after vaccine other than arm slightly sore similar to symptoms after a flu shot......Eight days after shot, breathing issue; thought might be anxiety issue (have not had that in over two years) or the fact that had not taken Advair for one week (meds to be delivered; however, have not experienced a breathing issue like this in years......went to be and woke up next morning with blotchy red spot by site of vaccine which had not been there before and it felt like a "bump" when pressure applied to the site.  January 22nd area on arm still red; am using hydrocortisone cream, no pain or discomfort
fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (mother) reported for a female patient (daughter). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at a 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, caller is supposed to get her 2nd dose tomorrow and her daughter had a fever, so they tested her for COVID, but the test came back negative, and she wants to know if it's okay if she still gets the COVID vaccine. She was talking to someone in Program but was disconnected. Provided Program number and cold transferred due to wait times. Fax to Program for AE, since she didn't clarify if she was having symptoms. Program. CEP 2191. The patient underwent lab tests and procedures which included COVID test came back negative. Outcome of the event was unknown.  Information about lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
pt recv vax 23MAY97 & 25MAY98 pt exp an allerg rxn;
burning, Itching,  Throat closing, chest pain and heart palpitation. I have been taking Benadryl since Sunday
5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions; No adverse event; patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (5 patients were administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered with the Moderna Covid 19 vaccine after these vaccines have surfer multiple temperature excursions).    No concomitant product reported by reporter.  It was unknown if patient received any other vaccine in the 4 prior to COVID-19 vaccine.  No treatment medication reported by reporter.  Case included information of patient 3 of 5 patients.
Blurred and double vision, brain fog, cognitive processing delays - all on the day following both vaccines
Itchy, bumpy rash showed up 8 days later in the area of the injection site. Rash lasted for 4-5 days. Approximately 4 inches by 2.5 inches in a rough circle. According to CDC website it is called 'COVID arm'.
Narrative: Fully vaccinated patient hospitalized for hypoxemic respiratory failure secondary to COVID-19. Admitted from home after passing out at home. Daughter found him down, notes that he had vomited and brought him in for evaluation 8/22/21. Was known to be COVID-19 positive on admission. Patient received remdesivir, dexamethasone and heated high flow oxygen. He was weaned to room air by 8/26. BP was labile during admission thought to be secondary to steroids. Medications were adjusted with recommendations for close outpatient follow up upon discharge. Patient discharged to home on 8/31 stable, on room air, with recommendations for home PT for strengthening.
This spontaneous report was received from a physician via field representative refers to a patient of unknown demographics. On an unspecified date the patient inadvertently received a fourth dose of GARDASIL (dose/frequency and route unspecified) (Extra dose administered). No adverse effects were reported. Outcome of event, extra dose administered was unknown. Reporting physician considered the event to be not related to GARDASIL. Additional information has been requested.
Sore arm, slight rash fatigue for 24 hrs headache for 36+ hrs elevated temp (99.7) for just a few hours - took 1000 mg of Tylenol slight numbness on left side of face/tooth sensitivity
About one minute following vaccine administration, the patient said he was going to pass out. He lost consciousness but was making snorting/snoring noises and was having muscle contractions that left him rolling around in his chair. This lasted about 2 minutes. He then turned very red and it appeared that he wasn't breathing. I removed his facemask and yelled his name/patted his chest and he began to regain consciousness. He sat for several minutes and said he felt fine.
pt recv vax & lab eval 1mo p/vax revealed a lack of serconversion;
Myalgia, Fever & Diarrhea Narrative:  Other Relevant History:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-JUN-2012, the patient was inoculated with ZOSTAVAX from a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster and post herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. On or about 17-DEC-2013, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, was prescribed Gabapentin for management of her painful symptoms and chronic pain and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
Information has been received from a health professional concerning a patient who may have inadvertently been vaccinated with Recombivax HB instead of Vaqta (MSD (lot#656680/0010U).  It was reported that if there was an error, it would be staff error only, not product quality complaint.  No other information is available.  Follow up information reported that the patient developed no reaction.  Additional information has been requested.
This spontaneous report as received from a pharmacist via a company representative refers to 8 patients of unknown age and gender. On an unknown date these 8 patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route not reported, lot# J008649, expiration date 10-JUL-2015) that was improperly stored in the refrigerator between 2C-8C and was reported no longer viable. Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Light-headed; erratic heart rate - heart rate monitored by self and fluctuated frequently between low 35 bpm to over 150 bpm; livedo reticularis on arms and legs. Photos and screen shots of heart rate documented and timestamped. I do not have a history of panic attacks and was not experiencing anxiety due to my COVID vaccine. I do not have a history of heart problems or arrhythmia prior to this incident. My normal heart rate is consistently between 52-60 bpm. and heart rate does not fluctuate erratically. I am certain my worrisome symptoms were associated with the Covid-19 vaccine from Pfizer. It appeared as though the vaccine created a cytokine-type storm in my body and my symptoms made me feel it was necessary to go to the ER.
COVID Vaccine Breakthrough Case  Moderna Dose 1 4/13/21 (016B21A) Moderna Dose 2 5/11/21 (041B21A) COVID Positive 12/1/21  12/1/21: The patient presents with Patient presents with hypoxemic respiratory failure due to Covid 19 pneumonia. He started having symptoms 6 days ago, with cough, sore throat, and congestion. He has had fevers and chills. He tested positive for Covid 19 with a home test 5 days ago. 2 days ago he began to have dyspnea with exertion, and now has dyspnea at rest.  12/3/21: Patient transferred via medic to Hospital. Patient alert, oriented, on 6L 02 per NC. Patient belongings sent with medic.  Nursing report called by evening nurse. Covid isolation precautions maintained.
Severe muscle spasms in arm where vaccine was given and the corresponding shoulder blade. Fluttering in chest.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies or concomitant medication were not reported. On 18-MAR-2016, the patient was vaccinated with a dose of M-M-R II (route, dosage schedule, lot # and expiration date were not reported). Then, on 07-APR-2016, the patient was vaccinated with a dose of VARIVAX (route, dosage schedule, lot # and expiration date were not reported) both therapies for prophylaxis. Additional information has been requested.
Reddened area (1 1/2 to 2 inches long), sore, and warm to touch at injection site.
per mom devel hives & c/o swelling all over body; taken to ER given Epi, Heparin lock placed w/2 does of another med mom states; returned home & rested; hives returned 730PM & 11PM; DPH given 730 & 11 for relief;recuperating from kidney inf
04/ 05/ 2022 1 month after vaccine I began having  tight of muscles in left leg numb Ness  from left butt  cheek all the way down to my acillies tendon numb on bottom of foot then knotty  muscle tissue  and tightly  tendon  un able to sit on toilet or stand on shower until I just could not stop crying Un able still to straighten leg it's still numb hurts my pelvic  to coughing  or sneezing burning sensations constant pain my heart has rapid beats laid my daughter had to wait on me hand and foot  I know what ciatica is and this is not ciatica this is very much different I have to keep the left foot under let butt cheek an lay on left side to not feel pain wakes me up constantly  feels like it's going to tighten a in 1 big not  could not move off the couch except to pee and  have to return to work I use to be able to stand for hours now minutes  before Charlie horse began to tight up  from but to foot feel shake y
patient came in for her covid booster (pfizer bivalent) and flu shot. after administration pt was sitting on  the blood pressure machine; a few minutes later the patient fell to the floor. Grandma threw her purse under her head to soften her fall. I ran out to the patient and she was already coming to. She was very pale, nauseous and light headed. we got her a coke, water and some chocolate. pt sat for 15-20 minutes on the ground. then we helped her to a wheelchair. She sat for a while longer until she felt better
fever; body aches; headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6206 and expiry date was not reported), via an unspecified route of administration, in Arm right, on 13Mar2021 at 02:30 PM (age at vaccination: 44-years-old), as dose 2, single for COVID-19 immunization. The patient medical history included hypothyroidism. Concomitant medications included synthyroid (Levothyroxine sodium). Previously patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not reported), via an unspecified route of administration, in Arm right, on 20Feb2021 at 12:00 PM, as dose 1, single for COVID-19 immunization. The patient was allergic to penicillin. The patient did not receive any other vaccine within four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 13Mar2021 21:30, the patient reported that, approximately 7 hours after she got vaccinated, she experienced extreme fatigue, and on 14Mar2021 12:30, 10 hours after she had a 102 fever with horrible body aches and headache. This lasted for about 30 hours until she started feeling better. The patient did not receive any treatment for the adverse events. On an unspecified date, the patient underwent lab tests and procedures which included body temperature of 102. Outcome of the events was recovered on 15Mar2021.    No follow-up attempts are possible. No further information is expected.
Pt recv vax on 1/26/99; on same day pt exp unresponsiveness, fixed stare & drooling, vomiting x 6-7 hr; tx=Phenergan
Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Leaking from Injection Site-
achy arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (achy arm). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (achy arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included blood pressure medications and cholesterol medication.
received immunizations listed below on 04/02/07. On 04/04/07 the child returned to the clinic with "red swollen right upper arm". +pain, +edema,+erythemia. Diagnosed:" cellulitis vs. delayed IGE hypersensitivity reaction"Treated with Keflex(250mg/5ml) 1 3/4 tsp. po bid X 5 days.
This spontaneous report from a contactable pharmacist. A 77-year-old female patient of an unspecified ethnicity received PREVNAR 13 on 25Feb2016, at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2016, about a week after she received the vaccine, the patient experienced redness, itchiness, warm to the touch and a little sore. The patient had not yet been recovered. Follow-up (28-APR-2016): Follow-up attempts are completed. No further information is expected.
Cry-encephalitis/encephalitic cry. Horrid shrieking, inconsolable, intense symptoms of pain. Motrin Administered.
Case was vaccinated and boosted as of October 2021, then was hospitalized for Covid in April 2022 Hospitalized at: Medical Center Case was hospitalized with cough, shortness of breath, O2 sats in the 20's (!), and recent history of bacterial pneumonia. Was treated with Dexamethasone, and DVT prophylaxis, and discharged home after 2 days.
Member reports post covid shot inability use shoulder/arm for greater than one week beginning the day after administration. Member states the shot was given much higher in her arm than other covid shots
Received third dose of Pfizer Biontech vaccine.  I had was sleeping and felt uncomfortable under the left arm where the vaccine was administered.  For three days I had a minor swollen lymph node and slight irritation.  And, slight pain at the injection site.  No other problems.  It went away.
At 3 am when I woke to urinate, I was very loopy in the head as if I had not slept at all for 24 hours. Kind of dizzy feeling. The next morning I was very tired. As time progressed, I felt like I HAD to be horizontal. No energy at all. No appetite at all. Took my temperature and was shocked to see it at 101.4º. Pharmacist suggested I take aspirin, which I took one, and then another one several hours later. It did help and reduced the fever to 99º.  The following day the temperature remained at 99º but under 100º. (I never took any other aspirin other than the two that I mentioned). The third day I was good to go!
Received telephone call from pt. on 8/16/12, c/o eyes and nose burning, neck pain and sore legs and arms. She also (pt.), c/o rash on arms and body. Pt. was advised to go to ER or call her pvt. Dr. Pt. called her Dr. and was advised to take BENADRYL. Telephone attempts to reach pt. on 8/16/12, 8/17/12, 9/20/12 and 8/21/12 were unanswered but LMOM. Pt. was reached per phone on 8/23/12, states she felt like she had the flu x 3 days but all symptoms relieved now after use of BENADRYL.
24hr extreme malaise (charley horse left calf)  left arm pain 24hr temporal headache 24hr
Patient's wife came into pharmacy asking about him as he had his flu shot earlier in the day and was now experiencing chest pains. Patient took 2 aspirin with no relief. Advised patient to go to urgent care for treatment of chest pain weather or not related to flu vaccine.
The pt experienced a 6 x 6 cm red, hot, itchy area over the injection site on right thigh. Treated with cool compresses and Benadryl. The pt was instructed to return to the clinic if fever develops and if they experience red streaks.
18OCT91 approx 5AM mom was weakened by a muffled cry; mo went into room & pt was curled tightly up & mom could not wake pt; called 911 & ambulance; Pt had 2 convuls;
One month after vaccines patient got a rash that started in the groin and has spread to his torso, front, back, arms, feet, neck. Rash has been treated with oral prednisone for 3 days and topical triamcinolone cream, which did not effect the rash. On 07/28/2017 a shave biopsy was done on two of the rash bumps. The biopsy result is a lichenoid infiltration of lymphocytes in the dermal-epidermal junction with damage of basal keratinocytes.
The injection site became hard and inflamed one week after shot was given. That has now been replaced by bleeding in exact spot of injection now some 13 days later.  Swelling has gone down and little redness around deltoid muscle is visible. Should I be concerned?