chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Large local reaction left deltoid-area 3 x 5cm of swelling, edema in deltoid no fluctuence with overlying intense erythema. 3/24/03 site clear-none states no redness and swelling.
Aches all over and in joints. Flu like symptoms. Mild Headache. Fever of 100.5 - low level. Lack of energy - tiredness. Took 2 - 4 Ibuprofen every 4 to 6 hours and slept 10 hours. Symptoms peaked at 24 hours and were pretty much clear after 40 hours after injection.
Information has been received from a physician concerning a 12 year old female with no pertinent medical history, who was very nervous and hyperventilation before receiving the vaccinations and it was reported that the physician "laid the patient down." On 15-AUG-2007 the patient was vaccinated with a first dose of Gardasil (lot # 657872/0515U). Concomitant suspect vaccine on 15-AUG-2007 included Varivax. Other concomitant vaccine on 15-AUG-2007 included MENACTRA. On 15-AUG-2007 after receiving all three vaccinations the patient stood up and fainted. Unspecified medical attention was sought. On 15-AUG-2007, the patient recovered from fainting. Additional information has been requested.
No adverse reaction-no problem to this point. Child under 2 y given FLUMIST instead of injection at a mass vaccination clinic.
blood pressure was elevated, blood pressure was high; Leg cramps; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (blood pressure was elevated, blood pressure was high) and MUSCLE SPASMS (Leg cramps) in a 65-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (blood pressure was elevated, blood pressure was high) and MUSCLE SPASMS (Leg cramps). At the time of the report, HYPERTENSION (blood pressure was elevated, blood pressure was high) had not resolved and MUSCLE SPASMS (Leg cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was received by the patient.  Treatment medication reported as due of the high blood pressure,patient was medicated with a high blood pressure medication.
Started with extreme pain in the upper are preventing the arm to lift laterally.  Anterior/ Posterior lifting was performed with minor difficulty.  Experienced chills in an indoor temperature of 80 degrees.  Extreme fatigued experienced from 7:30a.m. and through this current time.  Chills are coming and going as well as headaches.
Intended to give Pediarix (to 4 month old)-instead gave Tdap in error. No adverse effects noted.
Pt recv vax on 10/27/98; on same day pt exp crying, fever (104); tx=Motrin; 10/28/98 pt exp rash on legs, arms & trunk
Initial information received on 26-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 66 years old received vaccine FLUZONE HIGH DOSE which had a temperature excursion overnight. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Feb-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ051AB via unknown route in the left arm. It was a case of actual medication error due to incorrect product storage. It was unknown if adverse event was experienced. 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 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.
Initial unsolicited report received from a healthcare professional on 12 August 2015. This case is related to cases: 2015SA105654, 2015SA121736, 2015SA121739, 2015SA121740, 2015SA121741, 2015SA121742, 2015SA121743, 2015SA121744, 2015SA121745, 2015SA121746, 2015SA121747, 2015SA121748, 2015SA121749, 2015SA121751, 2015SA121752, 2015SA121753 (same lot number, same vaccine and same reporter). A twenty four months old female patient whose medical history and concomitant medications were not reported had received a dose of DAPTACEL (Pediatric SDV) (batch number: C4709AA, expiry date: 24 February 2017, dose, route and site of administration were not provided) on 06 July 2015. On 08 July 2015, 2 day post vaccination; the patient developed a red knot at injection site and 3-4 inch in size. It was reported that the patient did not require any medical attention or hospitalization. Laboratory investigations and corrective treatment were not provided. On unspecified date, the patient recovered from the above mentioned event (It was reported that few patients experienced the symptoms for a week while a few experienced the symptoms for one to two weeks). Follow up information received from a physician on 14 September 2015. The date of birth of the patient was provided. It was reported that 0.5 (unit not provided) dose of the vaccine was administered in the right thigh via intramuscular route. The patient developed a red knot at injection site which was 3-4 inches in diameter with redness and swelling. List of documents held by sender: none.
(No anaphylactic symptoms). Received HPV & MCV4 vaccines in (L) deltoid. Next morning woke up & whole (L) upper arm swollen, pt felt fatigued & dizzy, nauseous, hand numb. Arm progressively swollen & red. Seen in ED that evening, given ibuprofen, BENADRYL & ZOFRAN & started on clindamycin for cellulitis. Afebrile; arm swelling decreased, arm itchy. Clindamycin stopped by Pediatrician 1/12/12 - suspect large local reaction (allergic) to vaccine.
Right after vaccination recipient complained of abdominal cramping, IBS flare-up, dizziness, and anxiety. Patient has a history of anxiety and IBS. Symptoms did not resolve and patient was transported via EMS to the hospital for evaluation.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 23-year-old male. Neither medical history nor concomitant medications were reported. On 24-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Bells Palsy; This is a spontaneous report from a contactable consumer. A contactable consumer reported for a 20-year-old female patient (reporter's daughter) received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that, her received the vaccine. She was diagnosed with Bells Palsy on an unknown date. The reporter was Wondering what would be the likelihood that it was caused by the vaccine. She was 20 and due to this had numerous MRI and doctors' visits. The patient lab test included numerous MRI results was unknown. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Yesterday on 4/10/21 Received Pfizer vaccine and 5 minutes later developed heart racing, nausea, chill, chest tightness, and difficulty taking a breath. Patient was given Epi Pen and taken to ER by ambulance.  Given hydroxyzine in ER. Patient states today she feels Tired, chills, and her throat was thick. Throat thickness relieved by taking antihistamine.
Symptoms started 1 day after the vaccine (9-14-18). Patient reports rash around injection site, chills/shaking, fever, sweating, body aches, racing heart and a headache. When she reported to the pharmacy on 9-22-18 she was still suffering from a headache. She called her physician and they advised her to take TYLENOL and EXCEDRIN and then follow up with them.
IN ERROR, WAS GIVEN ADULT BOOSTER DOSE ONLY MODERNA COVID-19 VACCINE 0.25ML NO ILL EFFECTS
Information has been received from a healthcare worker refers to an the patient of unknown age. The healthcare worker reported the patient were administered an unspecified number of improperly stored doses of VAQTA (dose, route and lot# not reported). No adverse effect was reported. It was unknown if the patients sought medical attention. This is one of the several reports with the same reporter. Additional information has been requested.
About 12 hrs after injection, fever, chills, HA, flushed, conjunctival infection.
It was reported that a four-month-old male pt received Daptacel, C1526AA; Hib vaccine, UE02AA; and Synagis, TA5370B administered on 12/29/03. The next morning, the pt was found dead in bed with the mother. She had taken the child to bed with her at 7:30 am that morning and found him lifeless at 10:30 am. The autopsy status is unknown. The autopsy report received on 3/23/04 states SIDS. Oral thrush, diaper rash, plugged ear duct. From additional information received from another manufacturer, their reference number WAES0402USA00439, was provided. No new medical information was reported.  From additional information received on 14/Apr/2004 from a health care professional, the patient's birth weight, number of siblings, place of vaccination and how the vaccine was purchased were reported. No now medical information was provided.
Temp elevated night 100.9 F; ear pain; ear pressure; lymph node swollen behind right ear; severe neck pain; right cheek numb/sometimes left cheek numb feeling in lower cheeks/numbness in chin; hot flash in ears; chest pain; intense shoulder/shoulder pain/elbow pain; feels like it runs up the nerves; Pain in shot site left arm and pain in right arm in the same; severe headache/intense headache/pressure headache/bad headache; body pain at night; Pain in shot site left arm and pain in right arm in the same; This is a spontaneous report from a contactable consumer (patient herself). A 55-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm at the age of 55-years (non-pregnant at the time of vaccination), on 06Feb2021 at 01:45 PM at a single dose for COVID-19 immunisation. The patient's medical history included diabetes, high blood pressure, lacunar infarct, anemia, and non-rheumatic mitral regurgitation. The patient had no known allergies. Concomitant medications included losartan, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and acetaminophen. The patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient received other vaccine in four weeks was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID. It was reported that Immediately after the shot, severe neck pain that wrapped up my face, right cheek numb, hot flash in ears, chest pain, intense shoulder, elbow pain, feels like it runs up the nerves, severe headache, ear pressure, lymph node swollen behind right ear on 06Feb2021 at 01:45 PM. Headache, body pain at night on 06Feb2021. O7Feb2021, numbness in right cheek, sometimes left cheek numb feeling in lower cheeks and intense headache. On 08Feb2021, ear pain, pressure headache, shoulder pain, cheeks numb left work early not feeling good at all headache very bad with acetaminophen (TYLENOL). Second vaccine shockingly painful side effects day of shot and days after. Pain in shot site left arm and pain in right arm in the same. Temp elevated night 100.9 F. On 09Feb2021, Off work vice grip headache, ear pain. On 10Feb2021, bad headache, numbness in cheeks remain, numbness in chin. The outcome of the events was recovering. It was also reported that post vaccination, the patient had not been tested for COVID.
after recv vax in 3/96 pt exposure w/poss varicella 2 wk before break out of rash over body on 3/98
Medicinal sensation up in the upper palate of mouth about 3 or 4 minutes same sensation in the back of throat when I would breathe in I would feel; Almost like I could smell it; Medicinal sensation up in the upper palate of mouth about 3 or 4 minutes same sensation in the back of throat when I would breathe in I would feel; Almost like I could smell it; This is a Spontaneous report from a contactable consumer (patient).  A 71-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on 17Jan2021 at single dose for COVID-19 immunisation. Medical history included breast cancer. The patient's concomitant medications were not reported. The patient experienced medicinal sensation up in the upper palate of mouth about 3 or 4 minutes same sensation in the back of throat when she would breathe in she would feel; almost like she could smell it on 17Jan2021 with outcome of recovered on the same day. The patient reported that it didn't taste like anything that she could identify but it was just a medicinal taste. It wasn't metallic. It was just a sensation of an odd presence, an odd breath, an odd air or something in the back of her throat and up in her upper palate and it lasted for about 10 minutes and then it went away. The patient was not treated due to the events.
retinal branch artery occlusion occurred on May 31, 2021 resulting in permanent cloud damage to retinal area.  No history of high blood pressure, no history of high cholesterol, no history of diabetes.
Pt recvd vax 31JAN92 & devel high fever 105 in evening; mom gave pt APAP & a cold bath; following vax mom stated pt had mild convuls, jerking extremities;
24hr post vax pt exp chest pain & devel achiness, fatigue;adm to  hosp to r/o MI;hx fibromyalgia dx 10/97;rx w/multi meds/stopped in hosp & aches occurred p/meds;
2 hours after vaccination I noticed left arm started hurting . Went to bed at my usual time and woke up at 2:00 am with the chills I could not get warm late that night around 5:00 am I started having joint pain and fatigue with a headache and hot skin. I had taken my temperature and it was 100.7. I tried to wait out symptoms but I seem to bee get worse throughout the morning. Around 10:00 am I was in terrible pain and my body hurt all over. I once again took my temperature and it had gone up to 101.9. I had to call of work because I was so ?out of it?.  I started taking Tylenol ever 4 hrs for my fever and I was trying to hydrate.  My temperature slowly went down but still had body pain. I then started thank ibuprofen to help. Later that night around 9:00 pm my temperature was 99. The next day I called off work for fatigue and body pain. Today my temperature is normal and I?m starting to feel like my self again
Started a few hours post injection... Low grade fever, swelling on arm, nauseous, headache, coughing chills, sweats, not able to sleep.  Still feeling effects 3 days post injection.  developed large bump on arm near injection site.
Med error. Full dose not administered.  Syringe faulty. Administered full dose in addition to partial dose.
Awoke the morning after receiving the vaccine (approximately 19 hours post shot) with stiffness in my muscles. Arms, thighs, lower back and neck were all sore when moved. Throughout the next 12 hours symptoms increased in strength and spread to entire muscle system and joints of arms and hips. Throughout the 12 hours I also experienced alternating periods of chills and overheating as well as a migraine. I used an electric heating pad to warm various areas (feet, legs, arms, neck) from hours 30 to 33. I also used tylenol rapid release 500mg at 19 hours and then again at 43 hours. At 43 hours felt symptoms retreating to feel similar to 19 hours in. By 53 hours only slight tenderness in muscles remained. Muscle tenderness was gone at around 70 hours.
36 hours after injection developed generalized itching at injection site, also hives. Denies SOB or edema. Denies food allergy. Refer to PCP. Self-administered Benadryl.
I went to hospital for a third booster of a rabies vaccination. I was exposed to a bat. I had made a complaint to the hospital as they seemed reluctant to administer the previous time, even though I was provided with a first vaccine out of the country. After the third injection, I was choking throughout the night and had trouble breathing. When I woke up the following day I was too weak to move, extremely dizzy, had hot flashes, and felt very foggy. I inquired to the hospital why they seem to give me a larger dose than before, and am hoping to hear back from them. I went to my doctor for bloodwork who found everything ok aside from anemia and elevated liver enzymes.
Pain in both arms and hands. Numb fingertips. Feels like what i would expect carpel tunnel syndrome to feel like.   FIngers constantly swollen and tingly.  Can't bend fingers at night or when i first wake up. Nothing takes the discomfort or pain away.
Patient came in and stated arm had started hurting day after receiving the vaccine.  Informed patient that pain could last for a few months and to take tylenol or ibuprofen to help with pain in the main time.  Pt stated with follow-up with dr just to make sure.
Vaccinated at 12:00 19Mar2021.  Sore arm started a couple hours afterward and is still present. Started experiencing fogginess and feeling cold at 1:00 am 20Mar2021. Went to bed at 1:00 and dreamed of being sick until waking up at 8:30 am 20Mar2021. Woke up and was very weak (could not push toothpaste through toothpaste tube), almost passed out in trying, so I sat on the floor. Tried getting back to bed and was extremely nauseous and started vomiting. After that, I had the sweats/fever/chills for a couple hours (until ~11:00am), and was fatigued until 4:00 pm. Spent most of the day sleeping, unable to do anything. Today, 22Mar2021, feel slight tingling on palm of left hand and fingers. Injection site is still sore and bruised
Anaphylaxis within 10 mins after vaccines developed urticaria, pallor, lethargy, throat swelling and wheezing. Given EPINEPHRINE, PREDNISONE, BENADRYL and Xoprex in office and transferred to ER (another course of epi and had IV SOLUMEDROL).
On 4/13, I had an appointment for a second dose of vaccine. At night, I felt I was dying, because I had unbelievable fever. It was so much that neither I could sleep nor my wife because she felt that there is a heat on next to her. Also, I had a very bad headache and chili. I sweat all the night so much that all my clothes, pillow, blanket, etc got wet. I was feeling so awful that my wife wanted to call 911. On 4/14, in the afternoon, again my situation got worse.I was not able  to stand even for a short time, because I got dizzy immediately and my headache got worse Since I do not have insurance, I did not know what I should do. Which medication I should take, Where I should go. The only place that came to my mind was the center where I got the vaccine at. figuring out that it is closed by checking the work hour. I contacted the emergency room, and finally the next day on 4/15, I had to go to the urgent care, which I was charged around $400 for 2 IV's and a blood test, but I still had fever and headache
Information has been received from a physician concerning a 57 year old male with a history of shingles who in approximately April 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  In approximately April 2007, the patient developed shingles in the cervical-thoracic area.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Mom states the child was very irritable and experienced inconsolable crying following vaccination. The pt experienced a "subjective" fever at night. Woke up in the AM with a fine papular rash on torso, arms, neck. No rash at the site of injection. The pt was treated with hydrocortisone to apply to affected areas.
fatigue; headache; soreness; Unable to life the arm; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Flu shots (received many flu shots in the past and never had a problem with them.).   On 28th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2019-2020 season. On 28th October 2019, 5 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fatigue, headache, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the fatigue and headache were not recovered/not resolved and the outcome of the pain in arm and injected limb mobility decreased were recovering/resolving.   The reporter considered the fatigue, headache, pain in arm and injected limb mobility decreased to be related to Shingrix. It was unknown if the reporter considered the fatigue, headache, pain in arm and injected limb mobility decreased to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were provided as follows: At around 3:30, the patient received Shingrix in her left deltoid and a flu shot for senior citizens in her right arm. In the evening, the patient developed headache and some fatigue. The fatigue was so bad on the day of reporting that she had to cancel her plans.  She also said on the day of vaccination, her arm became so sore and she was unable to lift it but now it was much better. She never got headaches and never had an issue with any previous flu shots so she attributed her side effects to Shingrix. The patient did not consent to follow-up.
Horrific period. I have endometriosis and I know pain and bad periods, but following each vaccination dose I had breakthrough bleeding and heavy periods with intense pain. Today I had cramps so bad I was throwing up. I haven't ever had a period so extreme. I am just starting this cycle, but my last cycle following dose 1 lasted for 12 days and was relatively heavy throughout. This is not a reason to not get the covid vaccination, but women need to be made aware and more research should be done.
severe shoulder pain -no redness or swelling, but enough pain to prevent sleep.  Iced that day, administered tylenol and more ice following morning.
Patient had a fever the day after vaccine and took TYLENOL. Patient's arm is sore and red 3 days after.
Flu-like symptoms of body aches, GI issues like diarrhea, fever 101. This resolved quickly.
Apparent "Covid arm." 3-inch diameter oblong red rash below the injection site. Not itchy but slightly warm. First appeared about a week after the injection.
MEMBER RECEIVED ANTHRAX#1 AND SMALLPOX VACCINE ON 11 JULY 03.  YESTERDAY DEVELOPED DIFFUSE URTICARIA ON HIS TRUNK/UPPER EXTREMITIES WHICH RESPONDED TO BENADRYL.  ALL LESIONS COMPLETELY GONE APPROXIMATELY 2 HRS AFTER ONSET.  NO AIRWAY COMPROMISE/F/C/S/CP/SOB/N/V.  ASX TODAY.