chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion involving Opened IPOL, Reason: unknown, Max temperature reached: 47.1°F Duration out of labelled range: 15 minutes Human error: unknown with no reported adverse event; vaccines were used after the temperature excursion with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old male patient who was administered opened IPV (VERO) [IPOL] after temperature excursion, reason: unknown, max temperature reached: 47.1°F duration out of labelled range: 15 minutes, human error: unknown with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml dose (dose 2; frequency: once; strength: standard) of suspect IPV (VERO) Suspension for injection of lot W1A101M (expiry: not reported) via intramuscular route in the left deltoid for immunization.  On an unknown date, it was reported, temperature excursion involving opened IPV (VERO), reason: unknown, max temperature reached: 47.1°F duration out of labelled range: 15 minutes human error: unknown with no reported adverse event (product storage error) (unknown latency).  On an unknown date, the patient was administered IPV (VERO) vaccine after the temperature excursion with no reported adverse event (poor quality product administered) (latency: Same day).  No lab data was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA322119:
pt recvd vax 13APR91 & on 23APR91 pt had a pos pregnancy test; during pregnancy exp hypertension & edema; 29DEC91 pt delivered a nl  baby @ 40 wks gestation; baby's apgar scores @ 1 min & 5 mins were 8 & 10; baby's weight @ birth was 9lbs 2
Blood clot. Initial clot was felt in upper left leg/groin area on Mon 11/14/22. Didn't initially recognize it as a blood clot (had long assumed my 2 IVC filters would protect against them). After two days of not feeling well and increasing heart rate (resting pulse was about 150) and shortness of breath/hyperventilating, presented to Emergency Room on 11/17 at 11:30 AM. After blood tests, CTs, and Ultrasounds, determined I had multiple pulmonary emboli and a DVT in left leg. Put on blood thinners, as well as antibiotics and pain medications. After 2 nights in the ICU and 2 nights in a normal hospital room, was released from the hospital on 11/22/22. Was put on Eliquis, 5mg 2x daily (after initial 5 day loading dose of 2x 5 mg 2x daily)
Mom said her daughter experienced pain/tingling at the site an down her arm sunday after the shot and into today, 2 days later.
Sxs stared with left deltoid pain then progressed to nausea approx 7 to 8 hours after receiving the vaccine.  Assoc sxs: diarrhea, acute left-sided headache, acute  posterior neck pain and left eye pain & pressure & bilateral shoulder pain (left > right).   She has been taking Tylenol for relief.  Over the past 12+ hours, her symptoms have plateaued.
On month after the vaccine I was in the County Hospital emergency room wtih Afib.     My heart rate was 180 bpm and my blood pressure was also over 180.   The symptoms lasted for about 2 to 3 hours and subsided by themselves.    Since then the afib has returned more and more frequently and now I have an episode every day.
Swollen armpit lymph node on same side as vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18Feb2021 (Lot number: EL3247) 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: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen armpit lymph node on same side as vaccination". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
COVID VACCINE ON 03/15/2021 AND 04/12/2021 COUGH, FEVER, NASAL CONGESTION STARTED 01/07/2022
Immediately after receiving injection, she developed hives, approx 30 minutes later she develop shortness of breath and tachycardia. She was taken to ER. Treated with BENADRYL IV, solumedrol IV.
Noticed numbness and tingling after second shot but didn?t realize it was related to shot.  Unable to lift left arm. Had X-ray with no injury found. Tingling on left side worse with stress. Foot, left side of face, back of head. Had booster in December. Day after vaccination extreme soreness in arm and under left arm. Felt like lymph nodes were swollen. Felt better next day but tingling worse in foot and left leg, Dizziness in morning. Left leg feels numb. Exercise on elliptical and left hand pins and needles.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 16 years old adolescent patient and unknown gender. On 02-SEP-0214 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J015378, expiration date 09-APR-2016)(dose, route, were not reported). No adverse effect was reported. The outcome of events reproted was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
pain upon injection, and continuous pain at injection site (until date of discovery 12/8/20). Pt has been on a maintenence dose of prednisone, she has had to increase dosage due to pain
Dizziness; pain at site; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 09Apr2021 at 12:45 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications included ibuprofen (ADVIL), biotin (MANUFACTURER UNKNOWN) and vitamin D (MANUFACTURER UNKNOWN), all started from an unknown date for unspecified indication. The patient did not have any allergies to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 15Mar2021 at 13:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 17:30, the patient experienced dizziness and pain at site. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events dizziness and pain at site was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
2 days p/vax pt devel angioedema & hives;tx w/oral DPH w/resolution of sx;angioedema & hives recurred the next day & pt was again treated w/oral DPH;pt recovered;
TIA; Right side of her face was drooping; Left arm was paralyzed; Slurred speech; Dizzy; Confused; A spontaneous report  was received from a consumer concerning a 46-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced TIA (transient ischaemic attack), dizzy (dizziness), her left arm was paralyzed (paralysis), right side of her face was drooping (facial paralysis), slurred speech (dysarthria), and she was confused (confusional state).   The patient denied having any allergies, past medical history or concomitant medications.  Therefore, no medical history or concomitant medications were reported.  On 14-Jan-2021, the patient received the first of two planned doses of mRNA-1273 (Lot #: 251L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10-Feb-2021, approximately twenty-four days prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (Lot #: 16M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 06-Mar-2021 the patient had a "TIA" (transient ischemic attack). She was sitting down and when she got up, she got dizzy and her left arm was paralyzed. The right side of her face was drooping, she had slurred speech and she was confused. The patient went to the hospital where she was hospitalized for 2 days. The MD (medical doctor) said she had a "7 mm focal diffusion."  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcomes of the events, TIA, dizzy, her left arm was paralyzed, right side of her face was drooping, slurred speech, and she was confused, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Redness at (R) thigh started 1 day after receiving MMR/V. No fever, no swelling, no warmth to site. Not itching previously, but itchy today in office. 4x6 cm blanching patchy erythema, non tender, #2 MMR/V. T98.5. WT. 36.6 lbs.
The day of the vaccine, I started feeling a bad headache that was strong. I had to lay down. I felt very sleepy. Then my bones started hurting and I developed a fever. The next day it kept getting worse and worse. Then I developed difficulty breathing with chest pain. My chest was very tight and pain that was non stop. Nothing I took or did helped. I had 3 days of diarrhea and experienced weight loss. I went to my doctor on 7/14/2022, and took a COVID-19 test that was positive. I was prescribed a prescription PAXLOVID for 5 days. I still have a hoarse voice. I feel that the PAXLOVID has helped and my chest is clearing.
Pt recvd 4 doses of Engerix-B, 4th dose given on 11APR91 & pt converted p/the fourth dose;
PCV20 Vax given on 4/21 in clinic Sat morning 4/22 at 0530: chills, shakes, headache, dry heaves, fever 101 F by sat evening. Took tylenol and ibuprofen. Started to feel better on Sunday. Monday temp normal, red splotches on upper arm seen for first time.  4/25- Pt reported splotches turned into one large solid red area near where vaccine was given on left arm, tender, feels warm.  4 in x 4 in. Appetite better. No fever. RN reported to MD.  MD evaluated in office on 4/25: "I evaluated the patient myself in clinic today and her left upper arm was diffusely erythematous and warm on palpation with induration.  It does look to be a cellulitis and I recommended treatment with Augmentin 500 mg twice daily for 10 days, side effects reviewed especially as she has a knee replacement scheduled for May 11."
This spontaneous report as received from a healthcare professional refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-NOV-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot #L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
4/5 8:30am -Pain at injection site immediately, sore left arm  1pm  -Fatigure  2pm -Body aches and chills  6pm  -100.4 degree fever (lasted 4 hours)  4/6  Sore left arm, fatigue, nausea, right armpit swollen lymph node  4/7 nausea and fatigue  4/8 nausea and fatigue
MMR given @ pre-employment because of -Rubella titer on 12/5/01 area slight red & itchy after injection, but 3 days later redness larger and progressively getting worse (8 days later) with increased soreness, redness and heat 6x7cm with raised center, increased heat. Seen at urgent care as workers comp and given Keflex.
Severe vomiting, diarrhea, fever, nausea and severe headache. Significant Trembling and chills followed by high fever, disorientation and dizziness and fatigue. Symptoms started approximately 5-6 hours after shot - began with trembling followed by severe chills and dizziness - followed then another 4 hours later by fever, significant nausea and extreme vomiting and diarrhea - then loss of appetite, fatigue, dizziness. After 24 hours the severe symptoms stopped and there was just another 15 hours of fatigue. 40 hours later everything felt back to normal. Hour 6 to hour 30 after vaccination were horrible.
Extreme muscle pain in left shoulder lasting 3 days, then pain with movement still continuing now.
No additional AE reported; A vaccine coordinator reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a vaccine coordinator referring to a patient of unknown age and gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 25-MAR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose and route were not reported; lot # U022320, expiration date: 15-JUL-2023) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of minus 11.83 degree Celsius for a time frame of 15 minutes. Previous temperature excursion included 9.37 degree Celsius for a time frame of 2 hours and 30 min.   No additional adverse event (AE) information was provided (no adverse event).  This is one of the multiple cases reported by the same reporter.; Sender's Comments:  US-009507513-2204USA002815:
received Havrix that had expired; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number unknown, 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.   On 7th November 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th November 2022, unknown after receiving Havrix 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: 08-NOV-2022 Reporter's Comment: The physician reported that a patient (no identifiers available) received a dose each of Havrix (no lot number available) that had expired on 30th September 2022.  The reporter wanted to know was the dose valid. The reporter consent to follow up. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used. This case is linked to the case US2022163626, US2022AMR163547 and US2022AMR163515 reported by the same reporter.; Sender's Comments:  US-GSK-US2022163626:same reporter US-GSK-US2022AMR163547:same reporter US-GSK-US2022AMR163515:same reporter
Patient received J&J vaccine on 5/20/21. Presented to ER on 4/21/22 and found to be COVID positive. Presented to the ed for increased shortness of breath with exertion and orthopnea found to have heart failure exacerbation. Patient endorsing compliance with medications and diet. Does not adhere to 1L FR, but states he does not drink much more than that. Denies fevers, chills, chest pain, shortness of breath at rest, abdominal pain, nausea, vomiting, or diarrhea. Endorsing some constipation (last bowel movement 2 days ago) and paraspinal muscular pain to lumbar spine. Has been tolerating oral intake.   Vitals remarkable for hypertension. Saturating well on room air. No tachypnea. Labs remarkable for hypokalemia, elevated BNP, negative trop, SCR 1.50, baseline anemia. CXR unremarkable. Received no medications for COVID19 as did not require oxygen. Discharged on 4/24/22
Initial report was received from the scientific literature on 12 December 2012. The following is verbatim from the article: "In this study, the case of a 48-year-old man with severe serum sickness reaction in response to H1N1 influenza immunization is reported. He presented with renal failure and several of the classic signs reported in early descriptions of serum sickness including lymphadenopathy, urticarial skin eruption and facial edema. Serum immunologic studies and tissue histology/immunohistochemistry assisted in firmly establishing the diagnosis in this case. With appropriate therapy, the patient's rash, edema and lymphadenopathy resolved and normal renal function returned. This first reported case of severe serum sickness to H1N1 vaccine is particularly important in light of the Centers for Disease Control and Prevention's recommendation for universal vaccination against influenza, including H1N1, in patients 6 months and older. With increasing numbers of patients receiving this vaccine, even rare adverse reactions may be experienced by numerous individuals. It is imperative that clinicians remain vigilant about possible reactions and quickly institute appropriate therapy." Outcome was not reported. Documents held by sender: None.
pt recv vax 23OCT95 & pt devel severe inj site rxn characterized by pain & inflammation;pt has recovered;this is one of six patients from this site who exp the above rxn;
After receiving Moderna Booter (My previous vaccine was Janssen on 3/31/21) I received a Moderna booster shot at 11 am 11/6/21. Later that night my vision was compromised slightly, My eyes could not focus while reading.  It did not quite look blurry, but it hurt to look at the text and focus. Upon waking the next morning my eyes felt like they were burning  (mild to medium) and water was streaming out of eyes. When I looked in the mirror my eyes were bloodshot bright red. This improved throughout the day, but later in the day my eyes became itchy and red again.  I assume that this will go away with time, but I wanted to report it as a potential adverse event related to eyes/vision. Thank you.
This spontaneous case, initially received from a pharmacist on 25-Sep-2018, concerns a 66-year-old, elderly male patient. The patient had no relevant medical history and had not received any concomitant medications. On 19-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250789, expiry date: 30-Apr-2019]. On the same day, after vaccination, the patient experienced nausea, dizziness and almost fell down. The patient had recovered from the events. The reporter assessed this case as non-serious. Follow-up received from the pharmacist on 20-Nov-2018: The route of administration of the vaccine was confirmed to be intramuscular. The outcome of the events was changed from not recovered to recovered in the event tab. Narrative was amended accordingly.
Local reaction that worsened & dx'd as cellulitis in ER.  Responded to antibiotics.  IPV was given at injection site.
patient previously received both doses of Moderna and tolerated well. patients doctor ran spike protein test to verify immunity, even though patient is immunocompromised (therefore he was originally told the efficacy could be decreased). Patient states he was not immune and needed another dose of vaccine. patient and doctor were explained what the EUA allowed for us to do. Dr wrote script for patient to receive a dose of j&j vaccine.
Patient received the vaccine and felt fine. Had indicated no hx of fainting or dizziness, but felt nervous. Patient thought it wasn't as bad afterwards and indicated they felt fine. Patient had a seat in front of the pharmacy, started to feel dizzy but didn't tell anyone. Put her head between her knees, that didn't help and she figured she'd splash some water on her face, went to the bathroom and felt like she maybe needed to throw up, knelt over the toilet and next thing she knew she woke up on the floor.
Started with headache. Chills. Aches. Pain. Fever 100.4. Fatigue.   Very sick on the evening of September 15 through the 16th. Friday afternoon on the 17th headache fading, no fever or chills appetite coming back
14 month old had MMR 7.5 days prior to onset of fever early on 06/06/07/02. Had generalized seizure at 01:45, lasted 30-45 seconds and second one later that morning. Temperature at 08:38 = 101.7. Admitted.. Tests performed. Had one more brief seizure on 06/09/02, 03:35. Right arm and leg jerking, associated with temperature of 102.5. Maximum temperature 104.8 at 21:00 that day. Afebrile by the next day. No antibiotics or antiseizure medication. Dismissed 06/09/2002. F/U on 06/11/02. No more fever or seizure. doing well.
pt in error given 0.3ml pf covid vaccine for 12-17yr.  mom told while waiting in car at vaccine clinic and told vaers and report will be done and apologized to. discussed concerns and gave numbers to call if concerns
Local swelling and redness on site of injection. Pharmacist recommended ice pack and MOTRIN. Symptoms worsen next day, swelling continued on elbow. Went to MD, MD prescribed KEFLEX 500 mg TID for 7 days. Talked patient on 7-1-17, recovering fine.
9/15/2010. numbness and tingling of Left arm (where Vaccination was administered), achy and dull pain with minimal- to no relief with ibuprofen. Very limited movement of left arm possible.  Very hard, tender at injection site and entire left shoulder. 9/16/2010. Significant swelling of lymph nodes in Left neck, Left shouder, left axilla, Left clavicle. Signifcant pain in left shouder and arm that went to primary care doctor at 4pm.  Primary care doctor had never seen swelling to this extent from a DTaP vaccination before and urged me to return to ED at hospital where administered. 9/16/2010. Went to ED at hospital.  Dx'd me with cellulitis and gave me Levaquin and 600mg of ibuprofen.  9/18/2010. Swelling has subsided minimally and pain and achy is still present on scale 5/10.  Day 3 on Levaquin.
2 days later got worsening shoulder pain, Hard to move without pain medications including tylenol #3. It continues till this day 8/8/23 I had to prescribe her Naproxen 500 BID.
No other adverse effects were reported; they had administered a pediatric dose of PROQUAD to an adult; This spontaneous report has been received from a nurse practitioner referring to an adult patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-JUN-2023, this adult patient was vaccinated with a pediatric dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (route, strength, specific dose, frequency, batch/lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age).  No other adverse effects were reported.