chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2022 at 13:00 as dose 2, single (Lot number: FH9894) at the age of 77 years, in left arm and on 22Oct2021 as dose 1, single (Lot number: FH8020), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "migraine" (unspecified if ongoing); "Penicillin" (unspecified if ongoing); "Known allergies: sulpha" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course and investigation of conclusion: Patient did not receive any medications within two weeks. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot FH8020 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FH8020, fill lot FG3521, and the bulk formulated drug product lot FH0137. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
For 3 days and nights after the shot. FULL BODY  muscle spasms and FULL BLOWN ALLERGIES.  The 4th day, my body did not fill good at all. Thankfully I was  at work. I had a Stroke. Left sided chest pain. Left  arm was tingling. I had a sharp pain in my back. It went from left to right in my back. Went to the nurses desk. My blood pressure manually was 218/194. The nurse got it down. Now I am having further issues. Drooling on the left side of my mouth. My grip in my left hand is weaker, Since having this shot.
On 1/10/18 pt was brought in for an acute visit regarding a rash on the right leg. Although a significant amount of time has lapsed since the vaccine was administered, the rash that examined was most consistent with shingles in the exact location that the varicella vaccine was administered. The rash remained limited to that specific area before slowly resolving by 1/18/18 (the next time the patient was seen).
Severe migraine; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Severe migraine) and HEADACHE (Headache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033FZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Severe migraine) and HEADACHE (Headache). The patient was treated with AMITRIPTYLINE ongoing since an unknown date for Migraine, at a dose of 25 milligram once a day and SUMATRIPTAN ongoing since an unknown date for Migraine, at a dose of 100 milligram. At the time of the report, MIGRAINE (Severe migraine) and HEADACHE (Headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient called in to report on the side effects they had after having their first dose of Moderna vaccine. The patient experienced headache and severe migraine and even until now they were still not feeling okay been having migraine attacks from time to time.  The patient was taking Amitriptyline 25mg, every night before bedtime and Sumatriptiline 100mg for severe migraine.
When being carried by sister from clinic to car, pt went limp, became very pale, & vomited undigested breakfast cereal; Taken back into clinic mom & nurse observed mouth blue, appeared to have fainted but aroused quickly;
Information has been received from a pharmacist concerning a female who was vaccinated with a dose of VARIVAX (Lot # not reported) instead of ZOSTAVAX. it was stated that the reason was due to human error. The patient sought unknown medical attention. No adverse effect was reported. No other information is available at the time of this report. Follow-up information has been received from the office manager concerning about the female patient. She did not experience any problems and the event was reportedly his staff's error. The "staff member was too busy to look close enough to see they grabbed vaccine". Additional information is not expected.
At vaccination site I had the red itchy painful raised rash that was hot to the touch. I also experienced extreme fatigue, elevated temperature.  I fainted at work as a result from a dizzy spelled and chest pain.  I had periods of lightheadedness, dizziness, extreme fatigue, rash on my forearm on both sides, brain fogginess.
Redness, swelling, secondary cellulitis IV. KEFLEX 500 mg TID x 10 days. 10/27/17.
About 3:30 am. awoke crying which has never happen. Low feeling of depression lasted for 49 hours. Felt like a totally different human being. At that time, also experienced suicidal thoughts.
Immediately started to feel throat swelling, headache, eyes swelling and had to use 2 epi pens five min apart to get the symptoms to reside. Then a few hours later face, and throat swelling returned along with headache and went to ER for treatment with IV steroids
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 15-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
food poisoning; swollen lymph nodes in her neck; mild nausea; fever; stomach ache; sore throat; This is a spontaneous report from a contactable consumer (patient reported herself). The report was not related to a study or programme. A 25-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, in left arm, on 08Apr2021 at 3:30PM (at the age of 25-years-old), as single dose for covid-19 immunisation. The patient had no medical history, and no concomitant medications were received. No vaccinations were received by the patient within 4 weeks prior to the first administration date of the suspect vaccine. There were no adverse events following prior vaccinations. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). On an unspecified date, 2 weeks after the vaccination (08Apr2021), she got food poisoning. When she had the food poisoning, she had a stomachache and fever. she was also a little bit nauseous. It was reported that as per the patient thinking the food poisoning was not due to the Covid 19 vaccine. On an unspecified date, 3 weeks after the vaccination (08Apr2021), she got swollen lymph nodes in her neck and had a fever and sore throat. On an unspecified date, at the doctor office, she had blood work and an ultrasound of her neck where her lymph nodes were swollen, and for both the results were unspecified. The patient visited physician office, where she was seen by a doctor, who prescribed Penicillin VK 500mg one tablet two times daily for the swollen lymph nodes in her neck and her sore throat. It was a pharmacy bottle. NDC/Lot/Expiry not known. The patient did not visit any emergency room. She has not felt fully recovered until now. The outcome of the events was unknown. The patient wanted to know about the timing of the second dose as it has been 6 weeks since the first dose of the Covid 19 vaccine.  Information on Lot/Batch number was available. Additional information has been requested.
Family came in with child that had an appointment with a birthday of 10/09/2008. When asked the child repeated this birthday. When we checked Immunization Registry we found that the child's real birthday was 10/09/2009. Making the child 11 and not 12.
Vaccine was administered in the afternoon of 5/24/22. Pt states that she "had a fever and was itching all over" the night of 5/24/22. Pt denies rash/hives. Pt was advised to seek medical attention at local urgent care where she received a steroid injection and a prescription for prednisone.
Metal taste in mouth,  shaky, cold, throat thightness, difficulty swallowing, GI symptoms
Patient came to pharmacy with bumps on left arm and he said had some also on his chest. The red bumps also itched. He said this started shortly after receiving the immunization.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). No other medication in 2 weeks. There were no concomitant medications. Past drug history included: Morphine, reaction(s): "Allergy:morphine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" (2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of covid-19 included treatment of COVID-19with Paxlovid from 27Jul2022 till unspecified date in Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
From initial information received on 8/19/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that 15 patients (13 students and two teachers) received a TD ADS ADULT vaccination, lot number U1185AA, administered in the forearm on 8/16/04 in error instead of a TUBERCULIN PPD skin test. Later that same day, the patients experienced injection site redness, swelling, and granuloma formatino. Some of the patient's experienced headache, vomiting, syncope, tingling of the arm and hand where the product was administered and decreased used of the arm where the product was administered. All of the patients were taken to a local clinic, where the reactions were measured and photographed. The DOH and CDC were contacted. The recovery status of the patients was reported as unknown. The reporter of this case is the same reporter of cases 200402848 and 200402849.
Sore arm; This is a spontaneous report from contactable pharmacist. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced sore arm. The clinical outcome of sore arm was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
no adverse event; patient received a dose of Prevnar in June 2019/ patient then received a dose of Pneumovax 23 on 10/21/2019; patient received a dose of Prevnar in June 2019/ patient then received a dose of Pneumovax 23 on 10/21/2019; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in June 2019, the patient was vaccinated with a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (route of administration, anatomical location, lot #, and expiration date were not reported), for prophylaxis. On 21-OCT-2019) (also reported as 4 months after a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13)), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 1 dose (route of administration, anatomical location, lot #, and expiration date were not reported), for prophylaxis. The patient did not have any other adverse events.
Initial unsolicited report received on 02 December 2014 from a consumer (the patient). A female patient with a medical history of multiple sclerosis, experienced anaphylactic shock after she received a dose of influenza vaccine (manufacturer, lot number, date, route and site of administration not reported). Time to onset was not reported. The patient reported that she was very sensitive to things. About 5 years later, at the age of 54-year-old, the patient reported that after the 2nd day on AUBAGIO she started to have pain, "everywhere," her right side including her lip and tongue were numb, eye socket was painful, could not stand or lift right arm, and has been in bed for a month. She had to stop physical therapy. She is now starting to feel better. She went to the ER and was given a shot of DILAUDID and had an MRI. She was not admitted. She is on her second pack of oral steroids. She started COPAXONE. Documents held by sender: none.
side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Autoimmune disorder.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: positive (Positive) positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported that she experienced unspecified side affects after receiving the first dose of vaccine.   Concomitant product details was not reported.  Treatment details was not reported .   This case was linked to MOD-2021-220837 (Patient Link).
On November 13, 2022, I noticed I had a runny nose. I tested positive for COVID-19 on September 15, 2022. I was very fatigued and had a headache. I was having nerve pain in my legs and my hands. I tested positive until November 24, 2022.
Patient has a history of vasovagal syncope Received flu vaccine while laying on the exam table and felt dizzy Patient fainted for less than a second, legs and arms twitched and then she came to and stated, "I was on a road trip with hello kitty" Patient remained supine with a cool compress on her forehead and Dr was asked to come examine the patient  Dr came in to exam the patient at 3:25pm   Will repeat BP in 15 minutes after patient sits up Then recheck after 5 more minutes and see how patient feels
Received COVID and Flu shot together in left arm on Thursday and Saturday my are was swollen in a 4x4 inch area raised 1/4 inch off arm. Red hot ache spot. Lasted for 3 weeks
Left underarm has a painful lymph node. Blood clot on the same arm above the elbow.
A non-serious spontaneous report of motor tic manifested by head bobbing, has been received from a physician concerning a 12-year-old male, subsequent to FLUMIST. The patient had no medical history of any illness and was not on any medications prior to the event. The patient received FLUMIST on 29-Aug-2011. The patient developed a motor tic on 04-Sep-2011. The child did receive medical attention for the motor tic. The doctor described the event as head bobbing. The patient had been taking some ibuprofen for the discomfort caused by the head movements. The patient was seen on 07-Sep-2011 in the doctor's office. The event had improved since it began. It has been planned for the patient to see a neurologist. The event was recovering.
Intermittent Fever; feeling tired; This is a spontaneous report from a contactable 74-year-old male consumer reported for himself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:1140/ELI284) at single dose for COVID-19 immunisation on 10Jan2021 at 15:00. Relevant history was unknown. Relevant concomitant drugs which the patient received within 2 weeks of vaccination included: metropol tart, fluoxetine, vitamin d, allopurinol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Intermittent fever, feeling tired since 13Jan2021. Relevant lab test included COVID test (Nasal Swab) on 26Jan2021 with Negative result. The patient had no Covid antibodies detected after 3 weeks of first vaccine dose. Outcome of event was not resolved. Doctor or other healthcare professional office/clinic was visited. No treatment was received. Prior to vaccination,  the patient was not diagnosed with COVID-19.
Pneumovax (Right Arm) was Swollen And Patient Felt Hot. DiD Not Take Temperature.
Two scars from a previous shingles outbreak itched uncontrollably.  The patient put cortisone on the spots and they stopped itching within 2 days.  These spots were in a different place than the injection site.  The injection site was fine.
Immediately felt sensation going down my arm into my hand. Went to sit and wait and neck shoulder arm and hand began aching and feeling numb and tingly. Thought may be normal but still have numbness and tingling clear down to fingers. Hoping it will go away soo
Patient was inadvertently given a HIB vaccine that expired on 3/11/2023. Vaccine was given on 3/13/2023. Error was noticed after administration. Patient was monitored in clinic for approximately 30 minutes after receiving the vaccine, with no adverse reaction noted. Patient parents were notified before leaving clinic.
pt recvd vax & didn't feel well, next day chills & cold sweat, today body aches & stomach hurts; feels warm;
No adverse event; The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022; The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax on 22-Feb-2022. Past adverse reactions to the above products included No adverse event with Spikevax. Concomitant products included AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (MPOX CV [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) for an unknown indication.    On 07-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient had first dose given on 22Feb2022 and second dose was Moderna bivalent dose on 7Nov2022).    As per nurse there was an issue with one patient that had Moderna. The patient had first dose given on 22 Feb 2022 and second dose was Moderna bivalent dose on 07 Nov 2022. The patient was coming for a booster today 09 Jan 2023. The nurse would like to know which vaccine to give patient. No treatment information was provided.
Red rash, brick red; it's painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red rash, brick red) and VACCINATION SITE PAIN (it's painful) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 VACCINATION SITE ERYTHEMA (Red rash, brick red) and VACCINATION SITE PAIN (it's painful). At the time of the report, VACCINATION SITE ERYTHEMA (Red rash, brick red) and VACCINATION SITE PAIN (it's painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient did not receive any treatment in response to events.
SWOLLEN, RED AND PAINEFUL TO SIGHT.  UNABLE TO MOVE RIGHT ARM.  PATIENT STATES THAT WHEN ADMINISTERED SHE FELT WARM AND TINGLING SENSTION THROUGH OUT ARM BUT SUBSIDED SOON AFTER.  PATIENT WILL COME BACK 6/28 FOR FOLLOWUP. PATIENT TO APPLY WARM COMPRESSES TO SIGHT AND TO TAKE PAIN MEDICATION FOR PAIN.
Severe chest pain that felt like it was moving from injection site into left upper chest. Pain then moved to middle of chest then to right side and back and forth from 1:30am to 3:30am. Pain then became constant in left upper chest area near collarbone.  BP started at 156/95 around 1:45am then decreased to 127/87 around 2:30am
Vaccine was adminstered post expiration. A letter was sent to the patient's address on 2/17/2023 stating manufacturer's vaccine activity at the time of administration.   Manufacturer Statement: Pfizer reviewed the stability of the vaccine you received and determined that it likely did not maintain the activity necessary to protect against COVID-19 at time of administration. Pfizer cannot guarantee the protection you may have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you.