chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 61 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the subject experienced out of specification product use. On an unspecified date, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious.
This non-serious consumer report (initial receipt 03-Apr-2015) concerns a female patient who had a medical history of a sore arm and redness at the injection site after an unspecified bacterial meningitis shot. On the 04-Mar-2015, the patient developed a sore arm and redness at the injection site after VARIVAX. On an unspecified date, the patient received an unspecified influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed a sore arm. Outcome was reported as recovered.
Right axillary lymph nodes swollen to the size of an egg. 5/10 pain.  Range of motion decreased due to pain/discomfort.  Collateral symptoms include BLE calf cramping, fatigue, chills, and diaphoresis and only lasted 3 days.  Lymph node swelling/pain remains.  Treating with frequent application of heating pad to the right axilla for 15 minutes.  1000mg of Tylenol is being taken Q8h.
Swelling LUE warm to touch with area of erythema 12cm x 10 cm. No breathing issues. No other areas of involvement. Excessive localized reaction.
COVID Arm in left arm - palm-sized red rash  that is like a large version of hives. It itches like crazy. Responds to Benadryl  cream. The rash grew by about 20% today (day 3 since it appeared).
I started having vertigo every once in a while. It was frequent, but short. Like if you stand up really fast and it goes away, but it happened when I was sitting down. Around the 7th, it got worse and I sought treatment at ER. They gave me fluids, but couldn't find out why it was happening. It's been gradually getting better.
Moderna COVID-19 Vaccine EUA Light headed,  raspy throat, nasal irritation   Flu like symptoms     Treated with Tylenol.  Motrin and benedryl Symptoms decreased over next few hours
11:30a vomit  twice with fever 102 sweating and coughing then he took some nyquil stated at 9am has headache and bodyache  cough and sore throat
A report has been received from a Health Professional concerning a 10 year old, Female subject who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 31-Jan-2014. Clinical coordinator reports: we gave a dose of expired FLUMIST. The patient has not reported any adverse effects. The outcome of the event of GAVE EXPIRED FLUMIST is unknown. The reporter was considered to be non-serious by the company physician.
MUSCLE PROBLEMS IN THE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced muscle problems in the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of muscle problems in the arm was not reported. This report was non-serious.
Fever right arm pain, chills, exhaustion Narrative: Vaccine 12/28 1700 12/28 - 12/29 - overnight woke up several times feeling sick. He had chills. Temp was 99-100. Exhaustion. 12/30 - this morning symptoms his symptoms are still present but improved. Chills, exhaustion. Hasn't checked his temperature this morning. Right arm - hurt on 12/28 and resolved as of 12/30. He took off from work 12/29 - 12/30. 12/31 - Symptoms have all resolved as of later 12/30.
Fever and severe all-body soreness beginning 12 hours after injection (9PM), severe chills and shaking with fever by midnight (12AM), woken from sleep at 2AM by high fever and shaking . Temp almost hit 102 F, but came back down with Acetaminophen. Also had pain, some nausea, and gagged like emesis was imminent. Did fall asleep again. Temp was in range of 98-99 for most of the period 24-36 hours after injection, with and without fever reducing medication, but rose up to 100 around hour 33. Father reports similar development of symptoms from his vaccination experience, lasting 48 hours total. Is there a genetic link?
Syncopal episodes, increasing in frequency.  Tremors of left hand that are worse when patient uses this hand.  (she is left handed)  12/2/08 Reviewed PCP medical records of 7/29/2008. FINAL DX: headaches Records reveal patient experienced frequent left side frontal HA, staring spells, lightheadedness, blacking out for 30 sec-1 min x 6 mo & left arm/hand trembling uncontrollably & intermittently x 1 mo, lasting approx 1-2 hours each episode.  Referred for EEG, EKG, labs, MRI brain.  No results available.
4/21/2021   Patientwas observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  White coat syndrome, anxiety.   Assessment : Time of assessment 1110. Alert and oriented and White coat syndrome.   Actions taken: Water x1 Vitals sign taken  VAERS form obtained and completed by RN.  VS at 110- BP 130/105, P- 95, O2- 100%, recheck at 1114- 123/97, P- 89, O2= 99%       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.       Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 4/21/2021 11:07 AM  2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8735   NDC: 59267-1000-2          Electronically signed by RN at 4/21/2021  1:24 PM
After a day or so began to feel ache/pain in shoulder, elbow, wrist, finger joints, knee and ankle. Initially, I assumed this was the result of working in the yard, since I had had some left shoulder and knee aches in the past. However, I had not experienced elbow, wrist, ankle and finger joint pain like these previously. The pains in the elbow, wrist, ankle and finger joints were not severe but discomforting and somewhat limiting in some activities. The shoulder pain was more depending on position and what I was attempting to do. However, the shoulder pain may have been the result of specific activity and possibly aggravated by a possible reaction to the immunization. The knee discomfort may be similar. The reason I had not provided this information earlier was that I was not sure if there was an association between the injection and the subsequent joint discomfort experienced. However, after a discussion with others, I prepared the attached. [Note: I use a laptop and could not add the information on this page, thus I send it as a continuation/addition]. The joint discomfort occurred a day or so after the injection but I thought it may be related to working in the yard, the same day of the injection and subsequently thereafter. However, the joint discomfort continued and lasted about three weeks. Then the elbow, wrist, ankle, finger joint discomfort had subsided. However, I was continuing the same type of activity over this entire period. Also, I have continued this activity throughout the summer with no reoccurrence of the joint discomfort/pain indicated. The shoulder discomfort/pain continued but I feel that was related to what I was doing. Same for knee discomfort. I have not had any reoccurrence of the elbow, wrist, ankle and finger joint discomfort/pain after about the third week of July. As indicated, I am not sure the joint issues I had experienced were directly related to the immunization but had not experienced these indicated joint issues previous to the immunization. I am scheduled for the second "dose" of the HAVRIX, and will mention my experience related to the first "dose".
Systemic: Allergic: Difficulty Breathing-Mild, Additional Details: Patient came intoday for second dose and stated she had difficulty breathing the night of getting the fisrt dose which lasted for couple hours. Symptoms resolved within couple hours with rescue inhaler. Patient followed up with PCP with no follow up needed.
Patient is currently in jail and that is where patient received the vaccine.  He woke up the following morning with a full body rash and arm pain.  He couldn't raise arm up and here a month later he still can't raise his arm.
Autoimmune hepatitis; Fibrosis; This is a literature report.   A 49-year-old female developed abnormal liver function tests after receiving a single dose of the Pfizer COVID-19 vaccine. Subsequent evaluation indicated autoimmune hepatitis with bridging fibrosis, confirmed by a liver biopsy. Treatment with prednisone and azathioprine resulted in a favorable biochemical response. Conclusion: The incidence of vaccine-induced liver injury is rare, but clinicians should be aware of this potential adverse effect. The benefits of COVID-19 vaccines outweigh the risks of liver injury. It remains unclear if the vaccine triggers an autoimmune response or leads to de novo autoimmune hepatitis. Further research with a greater sample is necessary to understand the underlying mechanism and identify risk factors. Additionally, determining the optimal duration of immunomodulatory treatment is crucial. Despite rare cases, the overall safety and efficacy of COVID-19 vaccines support their continued use in combating the pandemic.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information. 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 ,Linked Report(s) : US-PFIZER INC-PV202300138373 Same article/event/drug; different patient.;
patient complains of hoarse voice, that is still present on 5/24/2021. The day after shot developed fever of 102, aches, chills.
Developed a low grade temperature starting in the early evening, and then it increased to a high of 103.5 °F by 10:30pm. I was cold, but I did not have the normal chills associated with a flu. I did not experience any upper respiratory symptoms except for chest tightness. I had a headache (mid-range) and also muscle aches. I took ibuprofen just before midnight so that I could sleep. I woke up with a temperature the following morning, and it was consistently between 102 and 102.5 °F for much of the day. I did not take any fever reducers until 10pm. The next morning, I was still running a temperature, but it was low grade. All other symptoms had dissipated.  By Sunday I was fine.  I did note shooting pains in my right leg around 2 weeks after the injection.
This spontaneous report as received from a physician refers to a 12 year old patient, gender unspecified. The patient's concurrent condition and medical history was not reported. On 20-AUG-2015, the patient was vaccinated with the first dose of GARDASIL (dose, lot number and route was not reported). The physician reported that the patient came in late for the second vaccination of GARDASIL and was administered the second dose on 19-MAR-2016 (inappropriate schedule of vaccine administration). No adverse effects reported. No further details provided. Additional information is not expected since the reporter did not wish further contact.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates since 11-FEB-2016, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L009545, expiration date: 19-MAR-2017, lot # L024268, expiration date: 01-JUL-2018 and lot # L027591, expiration date: 23-JUL-2017; dose and route were not provided) reconstituted with sterile diluent (lot # reported as L051109, expiration date: 25-MAY-2018 and lot # reported as L044086, expiration date: 02-JUN-2018). The vaccine and the diluent underwent a temperature excursion in range between 30 degrees Fahrenheit and 53.2 degrees Fahrenheit for undetermined amount of time, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
A non-serious spontaneous report of flu-like symptoms and nasal congestion has been received from a consumer concerning a 24-year-old female, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. On 05-Nov-2010, patient received FLUMIST. On 08-Nov-2010, patient started having flu-like symptoms and nasal congestion. The outcome of events flu-like symptoms and nasal congestion was considered unknown.
Patient is a 27 year old male with no significant medical history presents to MC on 2/6 from Urgent Care for further evaluation of chest pain. He states that he woke up at 5:30am with abrupt onset of chest pain with present like quality in the middle of the chest. It was non-radiating with associated nausea, small amount of emesis, and dyspnea. His pain lasted for about 15 minutes and he started experiencing it again after half an hour with numbness and tingling of his bilateral distal digits and diaphoresis. He decided to seek evaluation at local Urgent Care around 7:30am. States that he was immediately send here through ambulance due to findings of EKG changes. He was given aspirin and nitroglycerin with some alleviation of pain. Currently, he feels little better although continues to have chest pressure substernally every 45 minutes lasting 5-10 minutes. His dyspnea is resolved. He does not have pleuritic chest pain, fever, chills, nausea, vomiting, abdominal pain, diarrhea, leg swelling, rash. Additionally, he has been in normal state of health until this 2/2/21 when he received second dose of COVID-19 (Pfizer) vaccine. He had extreme fatigue with left arm soreness. He reports no sick contacts, recent illness, or travel. MRI cardiac done 2/9/21 with assessment reveals Infero-lateral myocarditis. Patient remained hemodynamically stable and was discharged with ibuprofen taper for 10 days, c/w colchicine 0.6 mg QD x 3 months and pantoprazole 40 mg QD
Very large and hard lump bigger than golf ball on front of left shoulder.  I called hospital 2 days later they said give it couple of days and if not better go to e.r. or go to Dr.  I went to Dr on 5/6.21.  He said contact Pfizer and they would guide me.  I contacted Pfizer and filled out form on their website.  I have not heard anything from them.  They apparently do not care about side effects.  It is 10 days since shot and no improvement.  I am worried.
p/vax pt arm black & blue; swollen at & around inj site; difficulty raising arm; tx: APAP; advil
Patient received 4 doses of PFIZER: 12/30/2020; 01/20/2021; 01/22/2021; 02/25/2021.
Hospitalization: 9/21/22 - 9/25/22. Presentation to the ED: ABNORMAL BP READING.  COVID-19 + date: 9/21/22. Treatment: Rocephin & azithromycin.  Discharge to: HOSPICE. PATIENT DECEASED 9/28/22.
The area where they injected the vaccine has turned into a large bump. The bump is about 2x2 inches, warm, red, and firm, but it doesn't hurt unless I poke it. I haven't done anything to fix it since it doesn't hurt.
armpit swelling; broke out a month later in a herpes simplex on her chest and back; This is a spontaneous report from a contactable consumer (patient's mother). A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient had some armpit swelling and she broke out a month later in a herpes simplex on her chest and back. She asked if Pfizer would probably want her to call even if it shows a month out and she never had that either. Consumer stated that she declines to complete a report for her daughter stated her daughter has all the timelines of all the breakouts and she does not want to give the wrong information about when she started having symptoms. Reporter did not specify seriousness for reported events. The outcome of the events was unknown.  Information on the lot/batch number has been requested
Information has been received from a 69 year old female with a history of shingles at age 32 who on 08-AUG-2007 at 15:00 PM was vaccinated with a dose of Zostavax (Oka/Merck). Exactly 24 hours later, on 09-AUG-2007 at 15:00, the injection site was red, hot, and hard and about 3.5 inches in diameter.  Soon after that, chills, fever, and nausea set in.  On 10-AUG-2007, the size, redness, hotness, and hardness had reduced in size to a bit bigger than a silver dollar.  The chills and fever had abated and the nausea was gone.  The reporter noticed that these were certainly not bad side effects compared to actually having a bad case of shingles.  She was going to have her physician take a look at the injection site in a few hours and take whatever actions she deemed was necessary.  No further information is available.
severe soreness at the injection site; soreness at the injection site was so severe that she was unable to sleep or lift her arm; soreness at the injection site was so severe that she was unable to sleep or lift her arm; Chills; mild headache; Nausea; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EC324U), via an unspecified route of administration on 11Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included penicillin allergy. Concomitant medications included unspecified daily vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), via intramuscular on an unspecified date at 12:00 pm at 56- years of age on the left arm for COVID-19 immunization and had only mild muscle soreness at injection site. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Jan2021, at eight hours post injection, the patient experienced severe soreness at the injection site. The patient stated that the soreness at the injection site was so severe that she was unable to sleep or lift her arm. On the same day, the patient also had chills, mild headache and nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event mild headache was not recovered while the other events was recovered on an unspecified date in Jan2021.
Patient reports redness and pain at injection site on her arm within the first 24hr of vaccination which resolved by 72hrs. She developed a rash on her L buttock and down the back of her L thigh starting 48hrs after vaccination- 3/2/08. She was examined in the office on 3/5/08 and found to have nl L arm, but classic Varicella zoster rash in a L S1 distribution. Was started on therapy with Vancyclovir that day. Culture swab of a blister was obtained.
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2008, at approximately age 63, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Fever of 100.5 Severe headache  Severe body aches Some nausea  All lasting about  18 hours Fatigue continuing past that
This is a spontaneous report from a contactable consumer (patient). A 55-year-old (non-pregnant) female patient received an unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 55, via an unspecified route of administration, left arm, on Apr 12, 2021, at 14:30, single dose, for COVID-19 immunisation. The patient has no reported medical history. The patient previously took Vicodin on an unknown date, for an unknown indication; and experienced allergy. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications included Aspirin (acetylsalicylic acid/ascorbic acid); Motrin (ibuprofen); Sudafed (guaifenesin; pseudoephedrine hydrochloride); Iron; Vitamin D; all for unknown indication from unknown dates, and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 12, 2021, at 21:00, patient experienced severe diarrhea. On Apr 13, 2021, patient experienced chills and sweats. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The clinical outcome of the events severe diarrhea, chills, and sweats recovered on an unknown date in Apr 2021. No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information expected.
Within a month after the vaccine, around May 22nd, I became chronically exhausted and was eventually diagnosed as anemic. My hair began to fall, I am chronically nauseated and my body/legs hurt. I am always exhausted now, it never stops. I have been to the Oncologist at facility and had 2 iron transfusions without it doing any good. I have been to my general physician several times and nothing has helped.  Dates of General Dr appts, 05/24/2021. 06/10/21, 09/13/2021, 011/04/2021, 11/09/2021 Dates of MN Oncology appts 08/09/2021, 08/16/2021, 08/23/2021, 08/30/2021, 11/05/2021  08/16/2021 - Iron Transfusion 08/23/2021 - Iron Transfusion