chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cannot lift left arm; injection site pain; This spontaneous case was reported by a non-health professional and describes the occurrence of MOBILITY DECREASED (cannot lift left arm) and INJECTION SITE PAIN (injection site pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced MOBILITY DECREASED (cannot lift left arm) and INJECTION SITE PAIN (injection site pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dose per day. At the time of the report, MOBILITY DECREASED (cannot lift left arm) and INJECTION SITE PAIN (injection site pain) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-044390 (Patient Link).
After leaving clinic, child's right arm was swollen with a nodule where an immunization was given, broke out with hives on trunk, back, arms; was taken to ER and given BENADRYL, no circled nodule to watch how large it got; right arm was red, hot and swollen
Extreme headache -24 hours 2+degree fever -12hours Mild fever additional 12 hours
This spontaneous report as received from a consumer refers to her husband of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, expiry date, dose, frequency, route and site unspecified). On an unknown date two weeks after having received the vaccine, the patient was diagnosed with shingles. The outcome of shingles was unknown. The reporter believed that the shingles was caused directly by the vaccine. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Pt reports hives spread throughout body.  Required ER visit, and prescribed Prednisone, Pepcid and Benadryl.  Denies difficulty breathing.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a patient who received all 4 doses of Prevnar before the age of 12 months. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was immunization. Product was administered on an unspecified date. Dose regimen was 1 drop. Concomitant medications were not reported. It was reported that the patient received all 4 doses of Prevnar before the age of 12 months inappropriate schedule of drug administration. The outcome is unknown. It has been determined that HQWYE704728SEP05 is a duplicate report of HQWYE703328SEP05. Therefore, the reports are being consolidated into HQWYE703328SEP05, which will remain the official case of record. No additional information was available at the time of this report.
Medical staff asked mom if she would like child to receive her 2nd COVID vaccine during child's visit with MD and mom stated "yes". Patient only had 1 COVID vaccine documented in WIR. After giving patient the vaccine medical staff was advised by mom that patient did receive 2 COVID vaccines in January 2022 (dad texted mom a photo of card as mom did not have it with her). MD aware and discussed issue with mom and mom denied questions/concerns.
persistent blurred vision; Weakness in the chest area; This is a spontaneous report from a contactable consumer, the patient. A 56-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 right arm on 30Mar2021 at 16:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included depression. The patient did not have any allergies to medication, food or any other products. Concomitant medications included bupropion hydrochloride (WELLBUTRINE) and clonazepam (CLONOPINE) for unknown indications from unknown start dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  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 09Mar2021 at 16:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 01Apr2021 at 22:00 the patient experienced persistent blurred vision, from 12 days, appeared on 2nd day after vaccine and weakness in the chest area (how one feels after a long flu with severe cough). The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events persistent blurred vision and weakness in the chest area was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
It had 2 kind of black dots and it is smaller; we did not notice it until we add the diluent into so we are not sure where it's coming from; The initial case was missing the following minimum criteria: [no adverse event]. Upon receipt of follow-up information on [17Oct2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF7708, Expiration Date: Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIQUID PRODUCT PHYSICAL ISSUE (non-serious) with onset Oct2023, outcome "unknown", described as "It had 2 kind of black dots and it is smaller; we did not notice it until we add the diluent into so we are not sure where it's coming from".  Causality for "it had 2 kind of black dots and it is smaller; we did not notice it until we add the diluent into so we are not sure where it's coming from" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: The LOT for the diluent GY5692 and expiration date is Feb2025. the patient had an issue last week, they had pulled a Abrysvo and wanted to get it ready and they thought they had corked it where there was some stuff on the rubber on the top that they had Cord and ended up into the shot. So they got rid of it then they had looked at another one and it had 2 kind of black dots and it is smaller and so they did not give that but got rid of the first one but kept the second one, reporter was not sure what that is so, they did not give that shot, so basically wasted 2 shots thats quite a bit. The vaccine was not used in any patient. The NDC on the actual is that 00069020701 but on the box is 00069034401. Reportability Determination: This is Medical Device Related. This complaint for I had an issue last week, we had pulled a Abrysvo and wanted to get it ready and we thought we had corked it where there was some stuff on the rubber on the top that we had 'cord' and ended up into the shot. So we got rid of it then we had looked at another one and it had 2 kind of black dots and it is smaller and so we did not give that but I got rid of the first one but I kept the second one I am not sure what that is so, we did not give that shot, so I basically wasted 2 shots that's quite a bit to us. I do not know what to do" for ABRYSVO INJECTABLE (VACCINE) is a reportable malfunction. If it were to recur, it could not likely cause or contribute to death or serious injury.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
1st dose 26-Sep-2020, 2nd 10-Oct-2020; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 10th October 2020, the patient received the 2nd dose of Shingrix. On 10th October 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix on 26th September 2020. The patient received 2nd dose of Shingrix early than the recommended trime interval, which led to shortening of vaccination schedule. The reporter consented to follow up.
Clusters of mouth ulcers formed on lip, tongue and cheek. Some very deep and painful, in the 3 days since I?ve experienced these, new ones have sprung up and none have healed
Information has been received from a physician concerning a 76 year old female with drug hypersensitivity who experienced an anaphylactic reaction on 25-APR-2007 after being vaccinated with a .65 ml dose of Zostavax. The reaction was described as racing heart, felt like throat was closing up, and tightness of the neck. The patient carries Benadryl Elixir 50 due to sensitivity to medication, which was administered. The patient was taken to the ER and administered IV famotidine and IV steroids. The patient was kept overnight for observation and released the next day. There was no product quality complaint. Additional information has been requested.
tired for a few days; This is a spontaneous report from a contactable Pharmacist reported for a female patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection Lot number was not reported) 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. On an unspecified date, the patient experienced tired for a few days. Caller is looking for information on any neurological side effects that can be caused by the Pfizer COVID-19 vaccine. He states his brother sent him a 29 minute long video of this doctor claiming that you are going to be a cripple after receiving the vaccine, caller sates in theory that could happen, but it would be so rare, this guy is just trying to scare everyone into not getting the vaccine and that is the last thing we need is for people not to receive the vaccine. He states he and wife had received the vaccine and he had a sore arm, and she was tired for a few days but nothing more than that. The clinical outcome of the event was unknown.  Information about lot/ Batch number has been requested.
fatigue Narrative: Patient reported sore arm and fatigue first 5 days Fatigue in the 2nd week. Patient is a recent heart transplant
Can not move right arm but received vaccine in left arm; right arm starting from her shoulder she has huge pain; This is a spontaneous report from Pfizer Support program reported from a contactable consumer (reported for herself). A 68-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0162/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 at 15:30 (at the age of 68-years-old) as dose 2, single for covid-19 immunisation at Pharmacy. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8727/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 (at the age of 68-years-old) as dose 1, single for covid-19 immunisation and experienced headache, body pain and feeling like she had the flu at Pharmacy. On 18Apr2021, the patient experienced cannot move right arm but received vaccine in left arm and right arm starting from her shoulder she has huge pain. The clinical course was as follows: Patient right arm starting from her shoulder she has huge pain, and she can't even move her arm, she says, but they put the vaccine in her left arm, and it is her right arm that is hurting. Reporter started with the pain, and she took neuropain for the pain and she took two Tylenol (Lot number: 201097A, UPC: 0904673060, Expiry Date: on an unspecified date in Mar2022) and reporter stating that, she will take another 2 to see if it gets better for the pain. Therapeutic measures were taken as a result of events included treatment with Neuropain and Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer and described the occurrene of allergic reaction in a female patient who received DTPa. On an unknown date, the patient received DTPa. On an unkown date, unknown after receiving DTPa, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to DTPa. Additional information received: The patient reported that she had an allergic reaction to tetanus when she was a child.
PATIENT CAME  IN TODAY TO REPORT A VACCINE REACTION FROM HIS FLU VACCINE REDNESS AND A SMALL BLISTER AT INJECTION SITE. REDNESS LASTED 24 HOURS ALONG WITH SOME SWELLING AND A LITTLE SCAB FORMATION AT INJECTION SITE. REDNESS HAD RESOLVED BY TODAY 10/22 AND INJECTION SITE SHOWED SOME SMALL SCABBING. PATIENT RECEIVED SAME FLUCELVAX VACCINE LAST YEAR WITH NO ISSUE.
Fever, malaise, joint aches, extreme fatigue muscle weakness/parasthesia above torso and left leg.
History of Present Illness:  This is a 88y.o. female with PMH significant for dementia presents to ED as brought by her grandson and DPOA for c/o leg pain and fall. History is limited as pt has hx dementia, A&Ox1 at baseline. Pt denies SOB, chest pain or any acute pain at this time, denies nausea. Pt's grandson states he took pt from nursing home and brought to this facility as he was unsatisfied with her prior care. He confirms pt was being treated for PE and Covid infection. States that she is mostly bed ridden and he does carry her. family has been watching her more closely since her falling In the ED, pt was afebrile normotensive and hypoxic on room air with improvement on 2LNC. BUN 36, creatinine 1.18, GFR 48. BNP 165. Troponin 0.04. WBC 9.9. COVID detected. Blood cultures pending. EKG - ST rate 72 with normal ST and non-specific T waves with prolonged qTc interval. CT head - 1. No acute intracranial process. 2. Nonspecific white matter changes, likely secondary to chronic small vessel ischemic disease. CTA PE protocol - 1. Significant bilateral pulmonary emboli burden with suggestion of right heart strain. 2. Scattered patchy ground glass opacities which could be seen in atypical/viral infectious process. 3. Main pulmonary enlargement which may be secondary to #1 or commonly seen in pulmonary arterial hypertension. Bilateral lower extremity doppler - 1. Deep vein thrombosis of the left common femoral vein. 2. No evidence of deep vein thrombosis of the right lower extremity. In the ED, pt was given 500cc saline bolus, duoneb NMT and IV heparin was initiated.
Starting approximately 12 hours after injection and lasting 12 hours: Headache Stuffy nose Aching muscles and joints (especially strong in old injuries from over year ago: broken leg and sprained wrist) Cold chills Fever and sweats Nausea Feeling faint Insomnia  Fatigue (lasting from April 11th to present May 25)
soreness at injection site; soreness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for an unknown indication.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 20th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Influenza vaccine Quadrivalent 2019-2020 season and not applicable after receiving Shingrix, the patient experienced injection site pain. On 20th November 2019, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent 2019-2020 season. It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received dose oh Shingrix and Flu vaccine on the left arm. On 20th november 2019, less than a day after vaccination with dose of shingrix vaccine, the patient experienced injection site pain. The patient received dose of Flu vaccine(unknown manufacturer) and experienced injection site pain. The reporter consented to follow up. This is 1 of the 3 cases reported by same reporter
PATIENT DISCHARGED AFTER 30 HOURS. 60-year-old with end-stage renal disease, history of renal cell carcinoma, type 2 diabetes who is regularly admitted for compassionate dialysis who presented 1/28 with signs of fluid overload over the 5 days prior to admission. He was found to be COVID-19 positive. Despite fluid overload patient is on room air. He underwent dialysis x2 with improvement in fluid status and resolution of hyperkalemia.
9/21 - 10am Vaccinated w/ Covid & flu, 8pm started feeling typical body aches, ickiness 9/22 - felt typical flu icky most the day, started getting better at night 9/23 - Back to normal from flu effects. Able to exercise. 9/24 - woke up itchy, afternoon hives began showing up 9/25 - intense full body hives with burning, itching, including scalp. Ears especially burned, itched and swelled. Took Benadryl 12pm - Full body hives getting worse, plus eyes, ears, ankles, fingers, and feet swelling. Feet so swollen, very painful to walk. Lifting big toe sent pain up my shin. Extremely achy neck pain in muscles, hard to turn head left and right.  6pm - Swelling starts to go down, hives still prevalent. 9/26 - Hives slowly fading, still itchy, but not burning.  9/27 - Mostly back to normal, hives mostly gone. Ache in shot arm at injection site when using muscle. Able to exercise. 10/7 - Shot arm muscle still slightly sore at shot location when using the muscle. Taking a long time to heal. 11/15 - Shot arm FINALLY back to normal
vomited; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced vomited on an unspecified date. Solution for injection. The outcome of the event was unknown.  Follow-up attempts are completed. Information the lot/batch number cannot be obtained.
Patient reports she got up to get a get a drink because she felt thirsty  so she went to get a drink and while she went to the self check out she passed out. Someone picked her up and walked her back to the clinic. Patient reports she is diabetic and didn't really eat a lot prior to coming in, and that she did have an anxiety prior to getting the vaccine. Patient sat in the lobby for about 30 mins after drinking a coke and eating some chips. HR 64, Blood pressure 108/68, RR 18 prior to leaving
Hypertensive, excessive sweating. Lightheadedness; EMS at bedside.
In mid-Jan 2022, congestion, cough, hoarseness, occasional low-grade fever, fatigue began and continues to present with periodic symptom relief through OTC and prescribed medications.
Information has been received from a physician concerning a 15 year old female who was vaccinated with a 0.5ml dose of GARDASIL (lot number not provided) on an unspecified date. After receiving GARDASIL she experienced a "heavy arm". It was unknown which arm was affected. The outcome was unknown at the time of reporting. The patient sought unspecified medical attention. Additional information has been requested.
Swelling , redness, tender and itching  1/29 am, Vaccine given 1/22
Pain and swelling in right arm then that night extreme ache in entire arm. Next day more swelling & little mobility.  Later in day rash appeared, fever, chills, body ached, arm extremely sore.   Went to ER on 4-15-12.
Information has been received from a physician concerning an 11 year old female who on 30-JUN-2010 was vaccinated with the first dose of GARDASIL (Lot# 663558/0819Y). Concomitant therapy included MENACTRA and unspecified poliovirus vaccine both on 30-JUN-2010. On 30-JUN-2010 the patient experienced an episode of full syncope with tonic-clonic seizure. The symptoms lasted 30 seconds. There was no lab or diagnostic test performed. The patient had sought medical attention in the physician's office and fully recovered there. Upon internal review, the syncope with tonic-clonic seizure was considered to be an other important medical event. Additional information has been requested.
Left upper jaw (cheek) pain and stiffness; Left arm and hand/wrist pain and stiffness; Entire body stiffness and pain - mainly joints and bones; Fatigue (mild); Soaking in hot bath. Took more turmeric. Rest. Eating healthy balanced meals. (Kale, walnuts, apples, Greek yogurt, peanut butter, high fiber cereal, etc.); Took my daily vitamin supplements. Coffee - this morning. Water; Doing my typical daily stuff. I've cooked, cleaned, done laundry, and just looking for employment. I've never had any adverse reactions to any vaccines, ever! This is the very first time I've experienced this in my life. I'm not sick. I have zero symptoms of anything else. To my knowledge, have not come into contact with anyone for any potential exposures.
Left deltoid area with redness and swelling warm to touch. Advised Tylenol Q4 hours cool compress. Return to clinic 3-4 days if not improved.
I received the COVID booster in my left arm and the flu shot in my right. For the first day and a half I had typical symptoms of a low grade fever, aches, and chills as well as very sensitive and sore skin everywhere. On the evening of the second day, when these subsided, I noticed my neck on the side of the COVID shot was swollen and tender. I looked it up online and saw that it was swollen lymph nodes and that the reaction was listed as ?uncommon? so I thought I better report it.