chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Moderna; Pfizer / BioNTech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Jan2021 as dose 1, single (Lot number: EL 3247), in right arm, on 07Feb2021 as dose 2, single (Lot number: EL 9264), in right arm and on 27Sep2021 as dose 3 (booster), single (Lot number: BA30125) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 4 (booster), single (Lot number: 046L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Colorectal Cancer", start date: 2019 (unspecified if ongoing), notes: Colorectal Cancer in 2019. Concomitant medication(s) included: ACETAMINOPHEN; LEVOTHYROXIN; TYLENOL. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 18Apr2022, outcome "unknown", described as "Moderna; Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid given from 01Dec2022 to 05Dec2022 as Covid-19 treatment.
Patient had delayed onset of menses and irregular menstruation x 2 months.  Also 2 months of moderate to severe dysesthesia/hyperesthesia of skin. High pitched tinnitus, continuous and ongoing at date of report.
Patient reports dizziness, nausea and red and swollen about 2 inches below the administration site.
The evening of vaccine, patient experienced fever, headache, aching bones, burning eyes, chest tightness. Some of this, patient attributes to anxiety from having an adverse reaction. Patient took aspirin. Fever resolved next day. Other symptoms resolved soon after.
Child diagnosed with 7 to 8 vesicular lesions- chickenpox. Had vaccine 8/7/00.
She got her vaccine, nothing at all for the rest of the day, felt energetic and good.  Then she started feeling like she was coming down with the flu, eyes were warm, achy.  About 2:30 AM she started feeling like she was freezing, went back to sleep and slept longer than usual and was then OK.  Was outside and started feeling itchy and felt it spreading and her injection site was redder than her husband who also had a vaccine that day.  She then started itching on her back and looked and then saw that her chest was covered, spread to her back, down to her buttocks region with radiation, lower back and all the way around her torso.  She took Benadryl 5 ml which helped a little bit, and took Benadryl an hour before the vaccine as well.  She did call her doctor and told her to take Benadryl or Zyrtec and were not able to see her.  They told her to come in to do blood work before her next vaccine booster.  She is still itching, and has not gone in to have allergy shots since the vaccine.  She goes every 29-31 days for her shots.    Has had allergic reactions to medications and vaccines in the past.  She had a reaction to Shingrix and Pneumovax which were given at the same time and had a rather severe reaction.
5 patients receive dose Moderna vaccine - punctured more than 12 hours ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients receive dose Moderna vaccine - punctured more than 12 hours ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients receive dose Moderna vaccine - punctured more than 12 hours ago). On 17-May-2021, EXPIRED PRODUCT ADMINISTERED (5 patients receive dose Moderna vaccine - punctured more than 12 hours ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
High fever by 3:00 am of 104, high pitch screaming and fussiness. By afternoon refused to eat with diarrhea. Took to doctors and was informed to alternate Tylenol and Motrin. Dr. also gave mylicon drops and mylanta. Temperature persisted. On 3/8/2008, child was in pain all over. Parent could not touch without child screaming in pain. Diarrhea still persistent. Child taken to ER where spinal was done. Child transferred by ambulance to another hospital. Blood work, x-rays were performed.  Treated for encephalitis, significant fluid loss, and gastroenteritis.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Mild, Additional Details: n/a
very weak; A little dizzy; High fever; headache; In the injection arm, a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (very weak), DIZZINESS (A little dizzy), PYREXIA (High fever), HEADACHE (headache) and VACCINATION SITE PAIN (In the injection arm, a lot of pain) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L2DA) for COVID-19 vaccination.     No medical history reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced ASTHENIA (very weak), DIZZINESS (A little dizzy), PYREXIA (High fever), HEADACHE (headache) and VACCINATION SITE PAIN (In the injection arm, a lot of pain). At the time of the report, ASTHENIA (very weak), DIZZINESS (A little dizzy), PYREXIA (High fever), HEADACHE (headache) and VACCINATION SITE PAIN (In the injection arm, a lot of pain) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment for the pain included ibuprofen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The events of pyrexia, headache and vaccination site pain are listed.
On 12/09/2022 had terrible sore throat, swollen glands, and stomach ache. Later that day I tested positive on at home COVID-19 test. By that afternoon I was very fatigued and had a fever of 101.5. Called PCP and was prescribed a Z-pack. Lost taste and smell for a day. Muscle aches and fatigue continued 14 days. I lost my sense of hot and cold in my hands for three days. I still suffer from minor fatigue.
The day after vaccine (2/26/2019) I had severe pain and redness at the injection site, fever, chills, headache, elevated heart rate (100) and fatigue that sent me to bed. By the evening my arm was so sore and I could barely move it. On 2/27/2019 the redness at injection site was 6" x 3". I thought I had shingles. Still experiencing fever, chills, headache, elevated heart rate and fatigue. Slept 12 hours. Today, 2/28/2019, the redness is still there but lessening in color. Have slight headache and fatigue. I looked up the side effects of the vaccine and the only treatment I took was ibuprofen and bed rest. I did not report this to my physician or Pharmacy after I realized I could report it online. I'm not sure I want to take the 2nd dose of the series.
Chest discomfort beginning in July 2021 and continuing to present. Diagnosed as muscular/skeletal after EKG, Echo, and stent placement.
Day 8 -swelling, left hand, fever 102 (F. Day 9 - rash, fever, itching, headache. Day 10- "flu like" sx - chills, hot.  Day 11 - blisters on right hand.  Days 14-16 - headache.  Day 22 - continues to have headache, right finger numb and aches.
102 Fever 6 hours, 100 fever another 18 hours.  Muscle aches and fatigue.
Lethargy, poor PO intake the day after vaccines given. He had URI and had been on BENADRYL x 1 d before vaccine. Propranolol since late July 2016.
Swollen, slight erthyma, and warmth around injection site (about 6cm diameter), appeared 8 days after injection.  Discomfort when raising/moving arm. Currently unresolved
Patient reports arm and leg pain (aching), extreme pain along with chills and low grade fever, mild headache.
Severe itching that seems spontaneous? like an allergic reaction, looks like hives on my shoulders, back, and lower torso area. I inevitably scratch and then it looks like pink, raised lines all over.  Usually disappears after 30-45 minutes but happens daily. Sometimes it?s not too bad, I started taking Zyrtec and that helps
Red area around injection site 1.5" x 3.5" for about three days starting 2 days post injection.
Discharge summary "Brief Summary of Hospital Stay: The patient is a 72-year-old male presenting to the emergency department with worsening leg abscess despite antibiotic therapy.  CT scan showed a large multiloculated abscess involving the subfascial gastrocnemius muscle and extending partly up into the subcutaneous tissues. Patient underwent incision and drainage of abscess on 11/1 with Dr. Noted surgical findings of copious purulent discharge with loculations.  Patient discharged in stable condition with additional keflex x 5 days. Wound culture results pending at discharge   Issues Requiring Follow Up: Routine post surgical wound check with Dr."
Developed a fever of 101 degrees 24 hours later. Fever subsided later that day.; This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A 17-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (reported as on or around 21Oct2019) at a single dose for immunization; and influenza vaccine (flu shot), via an unspecified route of administration on an unspecified date (reported as on or around 21Oct2019) at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient developed a fever of 101 degrees 24 hours later. The event took place after use of the product. The fever subsided later that day. Outcome of the event was recovering.  Information regarding the lot number has been requested.
Information has been received from a nurse practitioner referring to an unspecified number of patients. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot#, expiration date, dose and route unspecified, data logger) for prophylaxis. No adverse effects were reported. The vaccines were stored during 47 fahrenheitto 77 fahrenheitto for 2 hours and 30 minutes, during 32 fahrenheitto to 35 fahrenheitto for 60 hours and 20 minutes. No previous temperature excursion. This is one of the reports received from the same source.
was admitted on 1/20/2022 for chief complaint of weakness and anemia. Patient was found to have supratherapeutic INR as well as hypoxic respiratory failure secondary to Covid-19 with COPD and possible CHF exacerbation. Patient was treated with dexamethasone, ceftriaxone, and doxycycline. He also required IV diuresis for possible CHF. He required pRBC transfusion for his anemia.
This spontaneous report is the second of two reports (other case related: 1209USA001129) received from a Registered Nurse (RN) concerning a female patient in her 60's. The patient pertinent medical history and drug reactions or allergies were not given. On an unspecified date, one or two years ago, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX subcutaneously (Lot # and Exp. date were not given). No other co-suspects were reported. No concomitant medications were reported. The RN reported that on an unknown date the patient broke out in a very mild case shingles with a year or two after receiving ZOSTAVAX. No treatment was given. The outcome was reported as recovered/resolved. Additional information has been requested.
Patients mother stated the child's eyes rolled back, the patient lost consciousness, started "jerking", and had urinary incontinence. Pt woke up after about 30 seconds confused. Mother brought patient back into the clinic where the patient was evaluated, and then transferred to the ER for evaluation.
she felt her heart was squeezed really tight and had a similar feeling with anxiety attack; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer reported for herself that.  A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 30Jul2021 as (At the age of 48-years) DOSE 1, SINGLE for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced she felt her heart was squeezed really tight and had a similar feeling with anxiety attack. It was reported that Caller had the 1st dose of the Pfizer COVID 19 vaccine on 30Jul2021 the day after, she felt her heart was squeezed really tight and had a similar feeling with anxiety attack Asking if this is a reported side effects of the vaccine - She has been experiencing the symptoms until now. The outcome of evets was not recovered.  Information on the lot/batch number has been requested.
Fever and aches and pain the next day.  Lasted only one day.  I was asked to report this by someone who called from claiming to be related to VSAFE.
swollen gland on lt side-sore to touch-no fever; h/a 25AUG92;
6 days after both the 1st dose (given in May) and after the 2nd dose I developed hives that spread very rapidly. In May they lasted  2 days. They just started (following the 2nd dose) today. I have never had hives except these two times.
Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L008574, expiration date 22-NOV-2016 and/or lot # K02353, expiration date 22-MAY-2016, dose not provided) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had fatigue. I felt sluggish and I had nose drainage the next day and tested positive for COVID-19. I went to the clinic they prescribed me PAXLOVID, but I did not take it because my symptoms were so minor. I still have a running nose.
8 days after the booster I developed severe dermatographia. 2 days after that my reaction developed into severe painful and itchy hives / welts covering my body which was treated with oral + topical steroids and multiple types of antihistamines. The steroids worked for the hives / welts however the dermatographia has persisted to this day which means I am now going on 5 weeks of this reaction. I continue to take antihistimes daily although they do not seem to help.
8 days after receiving my second dose, I had  mid cycle menstrual bleeding, just like a period  and have now missed my regular period. Seems to be a direct correlation to the vaccine as I have never experienced this in my life.
welt that grew in size daily, hot in touch, arm sore for days, hard ball still after 2 weeks, nausea, diarrhea, loss of appetite, fatigue
Information has been received from a registered nurse concerning a 16 year old female who was vaccinated with a first dose of Gardasil (yeast). Subsequently the patient fainted. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information is available.
I have chickenpox for the 2nd time in my life !  I don't have shingles (they are painful, had those 2 years ago).  These look like 30+ bug bites from my breast area down to under my rump area.  VERY ICHY. BTW: Had the both shingles shots in June 2020 and December 2020.
Just minutes after my vaccine, the tinnitus that I already experience increased, and has never subsided.
Shot #2, Thursday,  4/1/21 8:20 am. 7 or 8 hours after shot: headache, chills, shaky, fever, nausea, extremely tired, loss of appetite.  Drank a lot of water and took Tylenol. Slept part of that night. Friday, 1st day after shot, slept much of that day, no appetite, slight headache. Saturday,  2nd day after shot, some discomfort in my left armpit?  but felt better that day. Sunday, 3rd day after, still left armpit discomfort but overall feeling near normal. No need to get medical attention.
Sore/achy feeling within 15 minutes of injection. Woke up around 0230am the morning following my second vaccine with a fever over 101 degrees Fahrenheit , body aches, chills. Fever continued to go up and peaked at around 102.2 degrees Fahrenheit. I felt lethargic all day and was unable to hydrate property or eat. I went to a local infusion clinic and was given a bag of IV fluids and a shot of toradol by a nurse to ease symptoms. Fever did not break until around 0100am on Jan 22, 2021.
About 30 minutes following immunization, the child's arm was very sore, she appeared to be weak and needed to lay down. She missed a day of school because she ended up taking a 4 hour nap. She woke up tired and had a loss of appetite. Stomach hurt too and she didn't seem to want to eat much the next few days. Decreased appetite. Following 4 days she seemed tired and wanted to take naps during the day. During the first dance activity on day 4, patient reported being dizzy, losing balance and needed to sit down. Energy level is still low.
had vax 4NOV92, knot on arm, 8NOV92 low grade fever; put on Erythromycin & hot compresses; 14NOV92 & 15NOV92 abscessed & hi fever; then put of Feflex 16NOV92 felt better;
Information has been received from a health professional concerning a 54 year old female with a history of penicillin allergy and mechanical low back pain who on 11-APR-2006 was vaccinated with dose of MMR II (lot # 649808/0488R). Concomitant vaccination included a dose of TWINRIX and tetanus toxoid. It was reported that the patient was vaccinated for overseas travel. Other concomitant medication included baby aspirin, calcium and ibuprofen. On 27-APR-2006 the patient developed swollen painful knees and was treated with anti inflammatory medications. On 28-APR-2006 she had red, swollen and painful wrists, hands and elbows. She was started on prednisone on 09-MAY-2006 for her painful joints and swollen hands. There was no product quality complaint involved. Additional information from the physician that indicated on 27-APR-2006 the patient woke up in th morning with severe pain in the right knee. She also complained of numerous other body aches that are associated with yoga. The patient denied any significant injury or trauma. She has had increased pain in her bands and wrist with numbness along the fourth and fifth digits bilaterally. The patient states at her job she dose a fair amount of hand work, no excessive keyboarding. No rashes or bruises were noted and vital signs were stable. The upper extremities were palpated. There was no pain over the ulnar tunnel. There was no pain tapping over the carpal tunnel. She had a negative Phalen's and negative Tinel's sign. She had normal strength distally. Normal sensation was noted distally. The knee was palpated and there was no laxity of the medical of lateral collateral ligaments and the ACL and PCL appeared intact. The impression was right knee pain and probable ulnar palsy. The physician suspected that the patient may have inflamed the ulnar nerve with her numbness and problems that she was having with her hand. The patient was treated conservatively; RELAFEN 75 BID was provided. Physical therapy was referred to help "calm down some of the inflammation". The patient was given recommendations to use an ACE wrap on her leg and hand. The physician also prescribed trazodone 50 mg Q HS to help her with sleep. On 01-MAY-2006 the physician spoke with the patient who was "doing better". The patient thought "it was related to vaccine for her international trip". She was till not 100%, but improving with physical therapy. She was seen at the clinic on 22-MAY-2006 and her knees were still swollen and she continued to take prescription anti inflammatory medications. At the time of the report the patient was recovering. The patient's experiences were considered to be disabling. Additional information has been requested.
Took shot at 11:30AM. Went home and took a nap 10 minutes. Upon awaking he broke out in a severe case of hives. Took him back to doctors office. Was told to give him Benadryl every 6 hours. Break out lasted 3 days. Complete recovery.
Headache, chills, shortness of breath, fever, body aches from shoulders to feet, fatigue, slight confusion.  Honestly, I feel worse now when compared to when I actually had covid.  Took Tylenol. When Tylenol wears off symptoms come back.
Hives (itchy) developed on both arms (upper arms) overnight following vaccination.  Given Benadryl orally.  Resolved with additional problems.
No adverse event; 18 month child inadvertently received the booster from 0.25mL from the Blue cap with grey border instead of the Pink cap; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (18 month child inadvertently received the booster from 0.25mL from the Blue cap with grey border instead of the Pink cap) and NO ADVERSE EVENT (No adverse event) in an 18-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Spikevax (LOT-AS1414B , Dose 1) on 05-Jul-2022, Spikevax (LOT -AS1414B and Dose 2) on 02-Aug-2022. Past adverse reactions to the above products included No adverse event with Spikevax and Spikevax.    On 26-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 26-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (18 month child inadvertently received the booster from 0.25mL from the Blue cap with grey border instead of the Pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (18 month child inadvertently received the booster from 0.25mL from the Blue cap with grey border instead of the Pink cap) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (18 month child inadvertently received the booster from 0.25mL from the Blue cap with grey border instead of the Pink cap).    No concomitant information was reported. It was reported that HCP stated that they've determined that the child received a higher dose and didn't need any additional assistance. No treatment information was provided.