chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 08-year-old child patient of unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour and continued for 2 weeks (explicitly coded as incorrect product storage). On 08-Feb-2018, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, batch number 195236, expiry date: 30-May-2018 and anatomical location: right deltoid and dose: not reported) which was stored out of recommended temperature (explicitly coded as drug administration error). The patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Non-significant follow-up received on 07-May-2018: Upon internal review, it was realized that the expiry date was incorrect. Hence, the expiry date was changed from 31-May-2018 to 30-May-2018 in the product tab. The reporter confirmed that, the patient had no adverse reactions from the suspect vaccine that underwent temperature excursion. Narrative was amended accordingly.
2 days after receiving the H1N1 vaccine, child became very tired all the time. He didn't want to wake up or eat. Parents made him eat even when he was half asleep. Lasted over a month. Mom states he is eating better at home now but still does not eat well at school. School feels he has become very thin and muscles appear "wasted".
I started to notice what felt like cold or numbness in my feet, which I thought was just the fan hitting my feet because I sleep with the fan at night. That feeling didn't go away. My feet feel like they're swollen, and it is more pronounced in my left foot and goes into my ankle on my right foot. It stayed in my toes and maybe in the past couple days it feels like it's moving up. Sometimes I've had shooting pain in my right toe, not frequent but it happened a couple months ago, and I felt something last night as well. The feeling is just constant and there's no pattern to it. It is a constant feeling of numbness, swelling, and I can move my feet and toes and curl and flex them and walk on them. It's just more so discomfort and neuropathy. I started going to PCP and I mentioned it to them, and they did a test and sent me to neurology and that was sometime in July (early) and they did a doppler and cervical and lumbar MRI, blood panel. I've had a few follow ups most recently because my c proactive protein was high, so I went to hematologist this past Tuesday 11/16. They did another blood panel and should have those results come back next week to see if anything that indicates the cause. Not sure exactly when it started.
Pain, erythema and onset of cellulitis  left upper extremity starting at the deltoid and traveling to ac space. 4-5 days later fever to 101.  Labs showed abnormal plasma lymphoid cells.
Was given without consent from POA patient got severely sick and never recovered later passed away only live 1 month POA did not allow second vaccine to be given just wanted to report this vaccine was given illegal without POA knowledge
Headache and body ache; Headache and body ache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache and body ache) and MYALGIA (Headache and body ache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache and body ache) and MYALGIA (Headache and body ache). At the time of the report, HEADACHE (Headache and body ache) and MYALGIA (Headache and body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Skin itches terrible especially when exposed to cold. Hives did develop on knees and upper legs. Itching was on hands, feet, legs and a bit on arms.
antibody screening test findings zero antibodies; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (antibody screening test findings zero antibodies) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (antibody screening test findings zero antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (antibody screening test findings zero antibodies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test negative: negative negative (Negative) negative.         Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant medication was not provided.  Treatment medication was not provided.
Varivax administered 2/11/08 RASQ 2/12/08 area of redness and warmth at site of vaccine injection (1x1 cm).  2/13/08 area of redness, increased 9x7 cm indurated.  Patient started on Duricef for possible cellulitis.
RED BUMP on torso; tingling all over his body/Tingling of extremity; Erythema; This case was reported by a pharmacist via call center representative and described the occurrence of local swelling in a 55-year-old male patient who received Herpes zoster (Shingrix) (batch number 43S97, expiry date 26th November 2021) for prophylaxis.   On 15th August 2019, the patient received the 1st dose of Shingrix .5 ml. In August 2019, couple of days after receiving Shingrix, the patient experienced erythema. On an unknown date, the patient experienced local swelling and tingling. On an unknown date, the outcome of the local swelling, tingling and erythema were unknown.   It was unknown if the reporter considered the local swelling, tingling and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced a tingling all over his body a couple of days following the vaccine. The tingling was primarily on his extremities and a red bump presented on his torso.  The reporter consented to follow up.
mom reports, that p/vax given on 5DEC94 pts slept all day & noc was difficult to arouse; slept too deeply & vomited feedings; no fever reported; pt recovered to nl next day
This spontaneous report was received from a registered pharmacist concerning an approximately 67 year old female patient with asthma and BENADRYL allergy. On 17-SEP-2013, the patient was vaccinated with dose 2 of, 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date were reported as H018380 and 12-MAR-2014 respectively), intramuscularly in an unspecified arm. Concomitant therapy included FLUVIRIN administered on 17-SEP-2013 in an unspecified arm. The patient thinks she previously (approximately on an unknown date in September 2009), received a dose of (dose 1) of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified). On 17-SEP-2013, the patient developed a rash at the injection site and soreness at the injection site. The patient sought medical attention (called pharmacist). She was treated with aspirin to treat the soreness. It was unspecified if any lab tests were performed. The patient was not recovered from the events at the time of report. The relatedness for the events was unknown for PNEUMOVAX23. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 03Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fever (103.7 degrees Fahrenheit); body aches; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever (103.7 degrees Fahrenheit)) and MYALGIA (body aches) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032M20A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL), HYDROCHLOROTHIAZIDE and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (fever (103.7 degrees Fahrenheit)) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (fever (103.7 degrees Fahrenheit)) and MYALGIA (body aches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) 103.7 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non Significant Follow-up; Reporter's Comments: NA; Sender's Comments: NA
Nov. 3 fever 99.4, lethargic, glassy eyes, involuntary twitching of jaw.
Client took oral typhoid vaccine on 1/31, 2/2, 2/4, and 2/6. After each dose patient report itchy legs and a rash on legs. Patient took BENADRYL and symptoms subsided by morning. Pt. took ZYRTEC before pill on 2/6 - has not reported outcome.
Patient called on 11/1/2022 and states after receiving her 2 primary doses of the moderna vaccine 3/31/21 and 4/28/21 she developed bilateral shoulder pain. She reported being examined for rotator cuff injury and was normal. She states over 1 year later she is unable to raise both arms and reach behind her back. She states she is unbale to dress herself without assistance.
This case is a cluster of 3 or 4 unidentified patients who experienced similar adverse events following vaccination with ADACEL. Initial report received from a health care professional on 12 April 2011. A group of 3 or 4 unidentified patients' received (dates not reported) an injection (route and site not reported) of ADACEL, sanofi pasteur lot number C3828AA. The patient's had moderate cellulitis after receiving ADACEL. A different individual gave the injection to each of the patients who reacted. Two patients had inflammatory reactions in the left upper arm and had received Td in the office within the last 5 days. It was unclear if they were allergic reactions or cellulitis. Both patients were put on antibiotics. The TDap that was administered to these patients had the same lot number (C3828AA) but were different vials as these were unit dose vials. The outcome was not reported. Documents held by sender: None.
Severe shaking that begin immediately along with spasm and anxiety.lower face and mouth spasm.neck very strong.arms woukd not stop shaking.hypertension.vision change not eyesfront of head brain pressure
7 days after injection, injection site developed a welt. The welt was tender, hot to the touch, swollen and itchy.  14 days after the injection, a red circle has developed. The circle is hot to the touch and tender.
Paleness, weakness BP prior to event 114/62, S/P 96/58 pulse 60 normal breath sounds.  Blood sugar = 82.
Trouble sleeping Day 1; sleeping 12 or more hrs for couple of days; itch and pain at vaxx injection; chills and tremors; high temps Day 2 (102.2-102.7); nausea; vomiting; diarrhea; headache and fog; physical fatigue; "dry" cough; body aches; weakness; trouble walking; loss of appetite. This was information given to the doctor's office. They advised reporting to this agency.  Since those first 5 or 6 days following vaxx and ongoing, I've randomly been having a sore throat and fatigue and fog/confusion. This is debilitating because of caregiving responsibilities.
Initial misuse report received from a healthcare professional on 07 October 2013. The 01-month-old patient had received PENTACEL vaccine. It's an inappropriate schedule of vaccine administered. No adverse event was reported. List of documents held by sender: none.
pt recv vax & exp varicella w/6 lesions;MD reported lesion occurred in few clusters on trunk & extremities;
On October the 15, 2021, I received my flu vaccine around 9am that morning.  I got my shot at work . Well at work I had no side effects but once I got home I started to have chills. On October 16, 2021, I woke up really hot. My husband check my temperature and it was 102.9.  My husband advised me that we should get check out.  Before hand I took my cousin to get surgery and come to found out she tested positive for covid-19.  I went and got tested on Saturday morning, October  16, 2021 at the  Medical Center, Dr. checked my vitals and tested  me for covid-19 and I tested positive for covid-19.  Dr. stated that there was noting I can take.  However, I've been taking cough medicine day time cold and flu relief  and honey lemon cvs cough drops and Vitamin C gummies.  I've been doing a breathing treatment 5000 Voldyne .  On Monday, October 18, 2021, I went to the Medical hospital and received a infusion of the  regen-cov.
around 2nd day have burning feeling in all my joints, migraine, upset tummy, and extremely tired. This went on for a  few days. I called my health care provider since I was feeling so bad. I called on Friday and heard back on Monday. Things had gotten a lot better.  Now since then my right shoulder hurts, and it never did before, When I move it it hurts, putting pressure on makes it hurt, I think it was caused by the shot. I have a apponitment with my doc on Tuesday to let them check it out. It has not gotten better and seems to be slowly getting worse, pain will go to my elbow and up my collar bone. I have never had this type of pain or issue before the shot.
Patient given injection with a dose that had been drawn up the day prior and left in the fridge overnight. No reported symptoms at this time.
swelling of lips; swelling of throat; change in voice; IgE (prior to ER trip) was already signif elevated; diffuse itching; hives; Itching became more continuous , hives increased; elevated dimer titer; This is a spontaneous report from a contactable Other-HCP reporting for self. A 70-years-old patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Feb2021 13:00 (Batch/Lot Number: EL9267) as single dose for covid-19 immunisation. Patient received the first dose on 20Jan2021. Medical history included Asthma, allergies to Penicillin, some molds, house dust, cat and dog dander. Concomitant medication included valsartan (DIOVAN); amlodipine; hydrochlorothiazide (HCT); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); bupropion hydrochloride (WELLBUTRIN). Within about1 week of injection, on 18Feb2021, patient experienced diffuse itching, site moving around, then later 2-3 hives. Patient had to d/c the antihistamine he take routinely (25Feb2021) for an allergy scratch test a week later. Itching became more continuous, hives increased. Had scratch test. Only localized reaction. Then hives increased, by 10Mar2021 hives bloomed all over body -- first on both forearms, then everywhere. Later in evening 10Mar2021, swelling of lips, throat, change in voice went to ER. Multiple Blood tests, chest MRI, neck ultrasound (localized swelling), cardiac stress test, and u/s of legs to r/o DVT because of elevated dimer titer (no clinical symptoms). All tests normal except dimer. IgE (prior to ER trip) was already signif elevated: 471 IU/ml on 25Feb2021 (Norm<114). Patient was hospitalized for these events for one day. Patient also Emergency Room Visit and Physician Office Visit for these events. Treatment included Inject of steroid, Benadryl, Prevacid, IV fluid. Patient had Nasal Swab on12Mar2021 with negative result. Outcome of events was recovered.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported events itching, hives, swelling of lips, throat swelling, voice alteration and IgE increased. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
HIVES within 24+ hours of vaccine (PCV13).  Also irritable, sore/stiff leg due to injection. Referred to doctor, given RX for oral steroid and antihistamine.
Patient states 15 mins after Moderna vaccine was given, patient had metallic taste in his mouth that lasted for 1 1/2 days. He also complains of palpitations that were so bad it woke him up - he still has some palpitations but not as bad. He also has tinnitus that is very intense that started a 5 days after his vaccine.
cold skin, headaches, dizzy, throwing up blood, shaking, heart rate was elevated, hard time breathing
Cold shivers, lethargic,no appetite, sleeping all day all night. Started to lose hair. Was able to go for a short walk on Sunday 31st.     Monday 1st Feb back to normal still loosing hair!!!
Pt recvd a series of 3 Hep B vax given 19JUN89, 01AUG89, 01FEB90 respectively; 1st & 2nd doses were w/? Hepatavax, 3rd dose w/Engerix-B; did not devel Hep B antibodies; 4th dose given 20NOV90 & did devel antibodies;
On the left deltoid area there are 2 circle band aids from two days ago. The top one: no reaction. The lower bandaid is reddened form 3.5-4" circular, hot, swollen and painful to touch. No central hardness. Pt complained of itching. I suspect this was the varicella shot. 8/20 FU telephone call. No erythema, no swelling/ "achy" when raises arm
Patient had no symptoms during 15 minute observation period.  2 hours later, she developed hives and nodules with itching and burning in the left arm.  She went to the ER where she was observed and treated with PO loratadine.
Multiple comorbidities - Cardiogenic/septic shock, Acute Respiratory failure, AKD stage 3
I received the first dose on Thursday, 2/4 at 2:30. By 3:45 I had the expected arm pain, but by 7:00 I felt as though I had the flu. I had aches throughout my body, had a terrible headache, was incredibly tired (I slept for nearly 20 hours straight), was nauseous, and had no appetite. Despite returning to work just 3.5 weeks earlier after maternity leave and, therefore, having very limited time off to use, I needed to use my only sick day on 2/5. I finally felt normal by about 6pm on 2/6.
On 11OCT91 pnu-imune given to pt; that evening arm felt heavy; following day arm was red from the inject site to the elbow & was itchy; no treatment; recovered;
Nurses reported a seizure. Pt was decerebrate posturing with arms and legs fully extended and stiff.Patient was sweating and lips are dry  Patient was laid down and given fluids. Patient vitals was monitored.  Patient became alert and walked out on her own. Dr recommend patient to go to the hospital but mom declined
This case was reported by a physician to a sales representative and described a child of unspecified gender who did not respond to immunization with Havrix, for prophylaxis. On an unspecified date in 2005, the subject received 2nd dose of Havrix "according to schedule." On an unspecified date in 2006 before 12 April 2006, less than one year after vaccination with Havrix, a hepatitis A antibody titer was negative.
8 days after shot, the site of the shot started getting red, hot and broke out with raised rash that eventually got rough & leathery feeling. Soon after my arm started getting irritated I broke out with large boil like spots all over my back of my head and back and down my right arm and some in my right hand. 2 days after breakout started I went to Urgent Care and got a steroid shot and antibiotics to prevent my sores/rash getting MRSA or Staph infection. Next day after I kept breaking out and my arm got hotter & more irritated and also started running low grade fever. Also had inside of vaginal area feel like skin was peel off & was very irritated and burnt/throbbed. So now 4 days later on Monday 4/5/21 I called to follow up with my doctor and she said not to get the 2nd shot and put me on a stronger 9 day steroid prescription and prescription ointment for vaginal area. She advised to make a report on CDC site of all my adverse reactions and that if I get any worse I am to report to the ER.
Flu-like symptoms. Headache, chills, fever, upset stomach, very sore arm for 24 hours. TYLENOL helped with the fever.
second instance of afib; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), at vaccination age of 56-year-old via an unspecified route of administration in the left arm on 06Mar2021 09:00 (Batch/Lot Number: EN6199) as a single dose for covid-19 immunization. Medical history included afib explained (no other issues) from Sep2020 (reported as 6 months prior) to an unspecified date and post first encounter was diagnosed with obstructive sleep apnea (began cpap treatment nightly). The patient did not receive other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient has no known allergies. Concomitant medications included metoprolol and omeprazole magnesium (PRILOSEC). The patient reported that this was only his second instance of afib. The patient reported that the second episode came 11 hours (also reported as 22:00) post vaccine (06Mar2021) and lasted for 10 hours (07Mar2021). The patient did not received treatment. The patient has not been tested post vaccination. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room visit. The outcome of the event was recovered on 07Mar2021 (reported as 10 hours after onset).