chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of cold in a 74-year-old female patient who received Flu vaccine (batch number 4ZP5141, expiry date December 2015) and (batch number unknown, expiry date unknown). Co-suspect products included ADVAIR Diskus inhalation powder (batch number 4ZP5141, expiry date December 2015). In 2011, the patient received Flu vaccine. On an unknown date, the dose was an unknown dose. In January 2007, the patient started ADVAIR Diskus (inhaled) 1 puff(s) at an unknown frequency. In January 2007, the dose was changed to 1 puff(s) at an unknown frequency. On an unknown date, the dose was changed to an unknown dose and frequency. In 2011, the patient experienced cold. On 5th January 2015, the patient experienced difficulty breathing. The dose of ADVAIR Diskus was increased. On an unknown date, the outcome of the cold was recovered/resolved and the outcome of the difficulty breathing was not recovered/not resolved and the outcome of the medication dose changed was unknown. The reporter considered the cold to be almost certainly related to flu vaccine and ADVAIR diskus. The reporter considered the difficulty breathing to be unrelated to flu vaccine and ADVAIR Diskus. The reporter considered the medication dose changed to be unrelated to ADVAIR Diskus. Additional information: A female patient reports that in 2011, she received a flu shot from an unknown manufacturer. No other information about the injection was known. The patient reports that as a result of the flu shot, she needed to see a doctor three times before the event resolved. The patient also reports that on January 8, 2015 she could not taste or feel the powder. She usually tastes and feels the powder. She reports that as a result of no powder coming out, she began to run out of breath. The patent reports that she only take one puff per day. During the event, she reports increasing her doses to one puff twice daily, but this did not improve or resolve the running out of breath.
Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received 2nd dose of BNT162B2 Covid-19 vaccine, at the age of 55 years old, on 24Mar2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Gillian Varre Syndrome - caused nerve damage & paralysis in hands and face. Ended up in hospital 19Apr2021. Outcome of the event was unknown.  Information about the lot/batch number has been requested.
Pt had just finished receiving above vaccines, seconds later she lost consciousness and fell forward off of exam table hitting her head on the floor, she had minor injuries of a bump over right eye, small laceration on her nose and bite her lip-had blood in her mouth. Father was called to come get her, we advised him to take to ER to check for possible concussion. She did admit to nausea but was oriented to person, place and time. She regained consciousness after approximately 45 seconds. Pt stated she did not remember getting the shot or feeling dizzy before she passed out. BP at 11:50 was 140/90. She was then assisted to sit up and then to wheelchair. Pt did complain of severe headache and tingling in both hands, denied vision changes. Pt taken to her father's car via wheelchair and again he was instructed to take her to ER. Treatment with ice pack to bump on head.
She had explosive diarrhea for an entire month, along with extreme irritability and fussiness.
2nd dose of Moderna COVID Vaccine administered 21 days after 1st dose to prevent wastage of expiring doses. No adverse reactions noted.
began running sl temp on 25AUg in evenings, Thursday noc became fussy & hot; 27AUG temp inc to 104 to MD-had ear infect, cutting teeth & react to shot all the same time;
DVT r leg on 2/13 Narrative:  found to have DVT r leg femoral vein down to calf- no known predisposing factors according to patient placed on NOAC for  next 6 months-meds started 2/16  Other Relevant History:
Red, warm, swollen below injection site. Approximately 4" x 6" area.
This spontaneous report was received from a consumer refers to his niece, a 7 years old female patient with allergic to gluten as an infant (the consumer thought that the patient had since passed). The patient was vaccinated intramuscularly with a "standard 1st dose in the arm" of GARDASIL on 09-AUG-2012. No concomitant medications were reported. On 09-AUG-2012 the patient broke out in red bumps all over her arms and legs. BENADRYL was given for the AE. It was being evaluated as to whether or not the patient would continue with the series of GARDASIL. There was no lab diagnostics studies performed. At the time of reporting, the patient was recovering. The patient did not seek any medical attention as the doctor told her to just take BENADRYL. Additional information has been requested.
Child starting complaining that her brain was hot and wanted a cloth for her forehead, however there was no fever. Next day she was lethargic, no appetite, and vomited. Two days later her arm swelled and was red and hot and painful from shoulder to elbow.
Rash on the face about 5-10 min after the vaccine. TX: Observation. Prescription for BENADRYL prn.
Fatigue, nausea, vomiting, erythema to L upper arm (are warm, swollen).
Initial report received from a healthcare professional on 12 September 2012. A 47-year-old male patient received first dose of FLUZONE intradermal (batch number: UT4470BA) in the left deltoid on 11 September 2012. The patient's medical history included latex and unknown if other allergies. Concomitant medications were not reported. It was reported that it was not sure whether the patient received full dose or some vaccine leaked out. On 12 September 2012, the patient developed wheal. The patient took the band aid off the next day and dabbed with a towel, the "blister" was seeping and when he wiped it off the skin came off. There was irritation in the shape of the band aid which was latex free. The corrective treatment and lab investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none.
Bilateral severe pain in both shoulders, hips, knees primarily.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL-9267) via an unspecified route of administration in the left arm on 17Feb2021 at 11:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, high blood pressure, chronic knee injury on left side, allergic reaction to Fluoroquinolones, and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had received other medication within two weeks of vaccination, which were not specified. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Feb2021, the patient experienced bilateral severe pain in both shoulders, hips, knees primarily. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included treatment with medication, physical therapy and the patient had undergone magnetic resonance imaging (MRI) on an unknown date in 2021, the results of which were unknown. The clinical outcome of the event bilateral severe pain in both shoulders, hips, knees primarily was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
feeling unwell; nausea; injection swelling site; fever; joint pain; Chills; muscle pain; headache; tiredness; This is a spontaneous report from a contactable patient. A 72-year-old elderly non-pregnant female patient received second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via unspecified route of administration on her left arm on 12Mar2021 at 13:00 PM (at the age of 72-year-old at vaccination) for COVID-19 immunisation. Medical history of the patient included kidney function abnormality (kidney functioning 30 percent). Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient was not tested with COVID-19. Concomitant medications were not reported. Past drug history included she received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E19267) via unspecified route of administration on her left arm 18Feb2021 at 13:00PM for COVID 19 immunisation. On 13Mar2021, she experienced headache, tiredness, muscle pain, chills, joint pain, fever, injection swelling site, nausea and felt unwell. Therapeutic measures were not taken to treat these events. At the time of the report, the events, headache, tiredness, muscle pain, chills, joint pain, fever, injection swelling site, nausea and felt unwell were recovering. No follow-up attempts are possible. No further information is expected.
acutely worsening shortness of breath requiring up to 90% FiO2 on high flow nasal cannula. Was treated for possible pneumonia. was able to come off of oxygen within two days.
This spontaneous report as received from a nurse refers to a 20 years old patient of unknown gender. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. The nurse reported that on 10-JUN-2016 and 24-MAR-2017 the patient was vaccinated with first and second doses of GARDASIL 9 (Strength, dose, route of administration, lot # and expiry date was not reported) for prophylaxis. Subsequently on 02-JUN-2017, the patient was vaccinated with third dose of GARDASIL 9 (lot # M034780, expiry date: 15-APR-2018) for prophylaxis. There was no adverse events. No product quality complaint was involved. Additional information has been requested.
PATIENT HAD PFIZER COVID VACCINE Dose 1 date: 12/31/2020,   Dose 2 date: 01/21/2021, AND TESTED POSITIVE TO COVID ON 9/4/21.
Lymph nodes right side of neck, shoulder swollen and sore.  Saw my primary care doctor who diagnosed.  No treatment was provided.  He did not give the vaccine, It was given at Pharmacy
could not sleep; tingling sensation in her eyelashes and they grew in size; tingling sensation in her eyelashes and they grew in size; soreness in the injection arm; dry mouth; Nausea; Soreness; feeling dopey; blurry vision; Sweats; fast heartbeat; low blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (feeling dopey), VISION BLURRED (blurry vision), HYPERHIDROSIS (Sweats), TACHYCARDIA (fast heartbeat) and HYPOTENSION (low blood pressure) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal. Concomitant products included VITAMINS NOS (DAILY VITAMINS), ASPIRIN [ACETYLSALICYLIC ACID], AMLODIPINE and ATENOLOL for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SLUGGISHNESS (feeling dopey), VISION BLURRED (blurry vision), HYPERHIDROSIS (Sweats), TACHYCARDIA (fast heartbeat), HYPOTENSION (low blood pressure), PAIN (Soreness) and NAUSEA (Nausea). On 06-Mar-2021, the patient experienced DRY MOUTH (dry mouth). On an unknown date, the patient experienced INSOMNIA (could not sleep), PARAESTHESIA (tingling sensation in her eyelashes and they grew in size), GROWTH OF EYELASHES (tingling sensation in her eyelashes and they grew in size) and VACCINATION SITE PAIN (soreness in the injection arm). On 06-Mar-2021, SLUGGISHNESS (feeling dopey), VISION BLURRED (blurry vision), HYPERHIDROSIS (Sweats), TACHYCARDIA (fast heartbeat), PAIN (Soreness) and NAUSEA (Nausea) had resolved. At the time of the report, HYPOTENSION (low blood pressure), DRY MOUTH (dry mouth), INSOMNIA (could not sleep), PARAESTHESIA (tingling sensation in her eyelashes and they grew in size), GROWTH OF EYELASHES (tingling sensation in her eyelashes and they grew in size) and VACCINATION SITE PAIN (soreness in the injection arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) Blood pressure dropped..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.   This case was linked to MOD-2021-254142.   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received contains No New information On 12-Jul-2021: Follow up received contains Updated Reporter contact detail,Added lab data and concomitant medications, Added New Events(Insomnia, Paresthesia, Growth of eye lashes, Vaccination site pain).Updated Outcome of all the events to Recovered.
R arm-localized reaction.  Rx: Medrol Dose Pak, ice, Omnicef.
-Stabbing Pain/ muscle spasms in left lower side/ near ribs -3 episodes that have lasted 2-3 days at a time 1 week apart
This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II nd ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Additional information 13Nov2012: MMR vaccine Date given 11/03/2012. Lot # 1571AA. Additional information has been requested.
02/15/07 12:00 onset of fever. Temperature not measure until 02/16/07 at 1425 at 102.7, 2 hours after proper dose of Tylenol.
"A bump/knot on my arm where I got the shot" customer said site is painful. I suggested ibuprofen/Benadryl/and a cool compress, if difficulty breathing/swallowing call 911.
Light-headed; Diarrhea; Puking; No appetite; Sweaty; Feet and legs got hot; Shaking uncontrollably so she put three blankets on and turned up the heat to 74°; Sick; Dying or having a panic attack; Heart was racing erratically; Bad headache; This is a spontaneous report from a contactable healthcare professional (patient). A 35-years-old non-pregnant female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose, via an unspecified route of administration, in the left arm on 29Mar2021 at 15:15 (Batch/Lot Number: ER8732) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient reported no known allergies. The patient did not received any other vaccine within four weeks of the BNT162B2 vaccine. The patient did not have COVID-19 prior to vaccination. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), hydroxyzine 25mg, paracetamol (TYLENOL), pseudoephedrine hydrochloride (SUDAFED), ibuprofen; all taken for unspecified indications, start and stop dates were not reported. On 29Mar2021, about three and a half hours after the first dose of the vaccine, the patient experienced a really bad headache at about 6:30pm. The patient did yoga from 7:00 pm to 8:00 pm, had dinner at 8:30 pm,  had a shower at 9:00pm, then right around 10:00pm she was lying in bed and her feet and legs got really hot. She started to feel really sweaty and sick then pressure in her butt. She went to the bathroom a few times first it was normal then it was diarrhea. She threw up about six times. Her throat felt weird while puking. She was sitting on the bathroom floor between puking and pooping and her heart was racing erratically. She was trying to calm herself down. She felt like she was dying or having a panic attack. After about 2 hours she was able to go in her room and lay in bed and she could not stop shaking uncontrollably. She put three blankets on and turned up the heat to 74°. She finally fell asleep but woke up at 5am. She pooped a small bowel movement and had no appetite. She didn't eat until noon but it was small (meal). She still hardly has any appetite today (31Mar2021). She has been light-headed off and on for 2 days. No treatment was received for the events. The patient did not get tested for COVID-19 post vaccination. The outcome of the events dying or having a panic attack, headache, feet and legs got hot, sweaty, diarrhea, light-headed, sick, puking, shaking uncontrollably, no appetite, heart racing erratically was recovering.
At 01/26/2005 Immunization appointment. Parents state they took child to ED the evening of 01/05/2005 immunizations. Child had fever over 104Fahrenheit. No other symptoms-0 seizures, 0 N&V. ED staff administered Motrin observed child x2 and sent child home on alternating Tylenol and Motrin protocol. Child afebrile within 24 hours No other problems. Mother was uable to recall if child had pre-antipyretic pre imm's
Chills, shakes, fever followed by liver failure & ascites. Liver Mets were negligible in 2/8/21 PET scan, yet 2.5 yes of chemo resulted in Pre-existing cirrhosis of the liver. ER visit on 3/3 with CT Scan and subsequent ER on 3/6. Paracinthesis scheduled for 3/15.
Syncopal episode following GARDASIL administration. Held in clinic for 15 min following incident, with BP initially 122/64 and 126/76 15 min later.  Given 12oz apple juice while reclining.
Pt states an hour after getting vaccine her Left arm started to get numb and tingle. Also stated that her neck and both arms became stuff as well as her fingers.
Headache, Myalgia, Arthralgia & ErythemaMultiform  Narrative:
Redness, itching and warmth, approx. 5 cm below injection site. Appears to be raised, well-defined border, approx. 10 cm x 6 cm. Prescribed triamcinolone cream. Reported much improved the next day with less redness and slightly less size.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)   An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Oct2022, outcome "recovered" (08Oct2022) and all described as "I got Covid on 01Oct2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2022) Positive, notes: I got Covid on 01Oct2022; (08Oct2022) Negative, notes: negative on 08Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Caller stated she read/saw there was concern for new Covid-19 variants. Caller asked if Pfizer is coming out with a new vaccine soon specific for new variants. Caller denies awareness of bivalent Omicron BA.4/BA5 formulation. Caller asked, How long after taking Paxlovid for Covid-19 should pt wait to get Pfizer's Covid vaccine. Caller stated, she got Covid on 01Oct2022 and was negative on 08Oct2022. Pt wasn't that sick. pt was just tired, had a little cough, no temperature. Pt will be 82 years old next week. pt had three doses of the Covid vaccine and a booster about five or six months ago.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Immunized on 8/15/05, presented to clinic on 8/23/05 with c/o left arm pain following Smallpox Vaccination. She was dx. with arm pain secondary to small pox vaccination. Received orders for Zithromax and Tylenol with Codeine. The evening of the 23rd she presented to the ER with increased c/o L arm pain with new onset stomach pain. She was diagnosed with small pox side effects and obstipation possibly due to the Tylenol with Codeine. She received a fleets enema while at ER and was recommended to use Ibuprofen or Aleve for her arm pain and to follow up the next day. Followed up on 8/24/05 with continued severe local reaction with swelling and pain to the L arm. Ordered quarters for 24 hours and Vicodin for the pain. Received notice on 8/25/05 that she was admitted to the hospital for Cellulitis of the L arm. Report noted that she was doing well and that she should be discharged back to her unit on 8/26/05.  1/9/06 Review of d/c summary confirms diagnosis of cellulitis.
No adverse effect; the patient was administered a dose of Pneumovax 23 less than 8 weeks after administration of Prevnar 13; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's concurrent condition, medical history, drug reactions/allergies and concomitant medications were not provided. On 04-NOV-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) 1 dose (strength, dose #, route of administration were not reported) (lot # R034249 and expiry date reported as 07-AUG-20120) for prophylaxis. It was reported that, the patient was administered with the suspect therapy less than 8 weeks after administration of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (inappropriate schedule of vaccine administered). No adverse effects were reported.
About 5 minutes after receiving the vaccine. The patient experienced dizziness, followed by accelerated heart rate.  Ambulance was called and patient was taken to the hospital as a precaution for observation.
Scattered red rash on the arms, legs,  across the face, (face was bright red).  I had small bumps on my chest and some larger ones on my spine up around my neck.   I itched.   Rash was gone by the next morning.   I did have an epi pen.   I had a reaction to Hepitites vaccine some 20 years ago.