chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had both a headache and a cough. I had mild temperature, the highest it got 99.5. My doctor prescribed PAXLOVID, I took it for 5 days and by the 3rd day all the symptoms disappeared with the exception of a mild cough that continued up until the 5th day. Currently I have no cough at all.
ADMINISTRATION OF VACCINE THAT WAS NOT PROPERLY STORED; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned an adult 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, route of admin not reported, batch number: 1820096, and expiry: 03-SEP-2021) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced administration of vaccine that was not properly stored. On 27-JUL-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine that was not properly stored and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210800873 and 20210800576.
No adverse event; Patient was administered pediatric monovalent vaccine instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered pediatric monovalent vaccine instead of bivalent booster).    Concomitant product use was not provided by the reporter. This case was for patient 14 of 16. Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:master case(same reporter)
Patient became unresponsive approximately 5 minutes after administration of influenza vaccine. She did not fall, no movement of limbs. Eyes remained open, pupils equal and round. Unresponsiveness lasted for 15 seconds. Patient immediately became Alert & Oriented x 4. Verbal, c/o "a little" dizziness.
ADMINISTRATION ERROR; INCORRECT STORAGE OF VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced administration error, and incorrect storage of vaccine. The action taken with covid-19 vaccine  was not applicable. The outcome of the administration error and incorrect storage of vaccine was not reported. This report was non-serious.
I am 23 weeks pregnant and due on or around September 27, 2021. The evening on the same day of the vaccine (my second dose), I felt very touchy, almost tingly, sore, body aches, and fatigue.
11/15/21 1804-2030:Irregular heart rhythm and high heart rate 150?s noted on iPhone  with palpitations  while at home. 911 called to evaluate, cardiac monitor showed sinus tachycardia.  BP 170/96 at home.12 lead ekg in ED appeared to be sinus, labs WNL. Discharged home to be evaluated by cardiologist within the next few days. 11/16/21: cardiac monitor placed for 2 weeks.
my stool have mucus and red streaks of blood; On April 4 around 1 or 2pm I have diarrhea; This is a spontaneous report from a contactable consumer (patient). A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Mar2021 13:30 as single dose for covid-19 immunisation. Medical history included Heart palpitations, anxiety, high cholesterol. Concomitant medication included omeprazole. On 04Apr2021 01:15PM, the patient experienced diarrhea, It seems to be getting worse and stool had mucus and red streaks of blood. Patient tried to see a doctor at urgent care. It was unknow that patient received treatment for the adverse event or not., since the vaccination patient did not tested for COVID-19. The outcome of events was not recovered.   Information on lot/batch number has been requested.
Lack of drug effect; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 09-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company Comment:  This spontaneous case concerns a 60-year-old female patient on concomitant Upadacitinib (Rinvoq) for Rheumatoid arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19, that occurred 7 months and 16 days  after receiving the second dose of mRNA-1273 vaccine.  SARS-CoV-2 test, and treatment were not reported. Outcome of the event was reported as resolved. Additionally, Drug ineffective was also noted. The 2-dose primary series of mRNA-1273 vaccine was given 30 days apart.  The concomitant Upadacitinib is an immunosuppressant that may slow down the immune system and lower the immune response to mRNA-1273 vaccine predisposing  to infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient on concomitant Upadacitinib (Rinvoq) for Rheumatoid arthritis, who experienced the unexpected, non-serious  adverse event of special interest COVID-19, that occurred 7 months and 16 days  after receiving the second dose of mRNA-1273 vaccine.  SARS-CoV-2 test, and treatment were not reported. Outcome of the event was reported as resolved. Additionally, Drug ineffective was also noted. The 2-dose primary series of mRNA-1273 vaccine was given 30 days apart.  The concomitant Upadacitinib is an immunosuppressant that may slow down the immune system and lower the immune response to mRNA-1273 vaccine predisposing  to infection. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Headache, fatigue, congestion; red and swollen at injection site , and rash on face 1/8-1/11/21 Increased redness, swelling and itchiness radiating out from injection site  (about the size of a hockey puck) 1/12-present
Pt stated that she had severe diarrhea and vomiting that lasted for about 10 hours following the vaccine (11/3-11/4). I asked if she took anything to help with the symptoms and she stated she could not keep anything down so she did not. Pt felt fine after the symptoms went away. I told pt to make sure her dr knows about this reaction as well and that I would report it and place a note on her profile.
Patient complained of generalized weakness approximately 10 min after receiving vaccine.  She was coherent and  monitored by pharmacy staff.  Patient asked that EMS be contacted.  Request was honored and patient was transported to local hospital ER for evaluation.
Patient is a 52-year-old female who is self-referred for evaluation of left arm injection site. Patient states that she had flu vaccination injection on 10/8/18 in the proximal left upper extremity. Patient states that she had flu vaccination injection on 10/8/18 in the proximal left upper extremity. Patient states following injection she noticed the proximal left upper extremity become "a little red". Patient denies drainage, fever, chills, sweats. States that the proximal left upper extremity is tender to palpation, which she rates 2/10. Patient reports positive lymph node swelling on the right side of her neck following the vaccination injection being given. Patient states the lymph node swelling has since ceased. Reports taking amoxicillin. Ultrasound ordered.
Patient's father reports increase high fevers and migraine headaches in the past year stating he is not sure if it correlated with the vaccine.
Information has been received from a certified medical assistant concerning an adult female (age not reported) who on an unspecified date was vaccinated intramuscularly with 0.5 mL of Pneumovax 23 (Lot# 651404/0352F). Concomitantly, the patient was vaccinated with influenza virus vaccine (unspecified). On an unspecified date, the patient developed an injection site reaction that included local heat, pain and redness at the injection site. The patient sought unspecified medical attention. At the time of this report, the patient had fully recovered from the events (date unknown). Additional information has been requested.
Treatment of COVID-19 / Rebounded infection / Still suffering symptoms and testing positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Treatment of COVID-19 / Rebounded infection / Still suffering symptoms and testing positive) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Treatment of COVID-19 / Rebounded infection / Still suffering symptoms and testing positive). At the time of the report, COVID-19 (Treatment of COVID-19 / Rebounded infection / Still suffering symptoms and testing positive) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: tested positive (Positive) Tested positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  Patient took unknown drug with indication COVID-19 Treatment on 05-May-2022 and stop date 10-May-2022.  The patient was not taking other medications or products within 2 weeks of staring COVID-19 treatment. The patient previously received a unknown COVID-19 vaccine. The patient had rebounded infection after completing the 5 days, but still suffering symptoms and tested positive. The device date 19-May-2022.  Company Comment: This is a spontaneous case concerning a 72-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. SARS-CoV-2 Test was positive, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 72-year-old male patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine. SARS-CoV-2 Test was positive, no other clinical or treatment details were given. It was reported that the outcome of the event has not resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report was received from a female patient of unknown age, who is also a nurse, referring to herself via a company representative. The patient's medical history, concurrent conditions and allergies were not reported. On 08-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported. Other suspect and concomitant therapies were not reported. On 10-OCT-2015, the patient experienced injection site vesicles described as blisters at the injection site. On an unspecified date in October 2015, she was evaluated at an unspecified emergency room; she was diagnosed with cellulitis and was prescribed an unspecified antibiotic medication. The outcome of cellulitis and injection site vesicles was unknown. The relatedness between cellulitis and injection site vesicles and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Left thigh red, hot and raised area.  No fever. No drainage. Redness not spread much since first appeared same day of immunization (4/23).  Use ice packs, Motrin & Benadryl. If no improvement or worsens call & then will treat for cellulitis.
My arm felt swollen or like it was filled with liquid. I checked my arm and it appeared normal but it didn't feel normal. Days passed and I thought it would subside but it started to hurt in one spot on my elbow. It never went away. I finally went to my primary doctor and she prescribed 2 weeks of Ibuprofen. The medicine did not help. It became increasing worse. I couldn't do anything with my left arm or pick up anything. The pain stayed localized to the one area but eventually moved around the same location. I went to a doctor at the clinic and was treated for lateral epicondylitis. I received PT 2x a week and wear a brace on my left arm.
Head-banging, arm flapping, punching, extreme need for human contact, hypersensitivity to sensory stimuli.
Patient presented to the clinic with complaints of itching, soreness and swelling at the injection site.  Symptoms appeared localized and patient was instructed to use benadryl cream and ice packs through resolution of symptoms.  Contacted patient 9/13 for follow-up: Soreness has resolved.  Itching still remains - placing benadryl three times daily to site.  Patient has an appointment with NP on wednesday.  If not resolved by then, patient will review with NP
Got shot 2p on 7/28. Felt fine until I went to bed at 10p. Woke up at 6a and felt extremely nauseous,  lightheaded when laying/wanting to pass out when standing or walking, had a fever of 101 (normal temp when not feeling well is lucky to get to 99), painful arm, and headaches. Felt all these symptoms until I went to bed at 930p. Woke up 7/30 at 6a and felt back to normal minus sore arm and slight headache.
Cellulitis to left thigh 2 1/4 x 1 1/2 inch area of mild swelling with 1 inch x 1 1/4 inch; Augmentin (600/S) 6 me po BID x 10 days
Pt vaccinated with Recombivax HB three months before she became pregnant. At four months gestation, amniocentesis showed that the fetus brain was displaced outside the skull. A therapeutic abortion was performed. Add'tl details requested.
Left arm has swollen and become painful. Pt was unable to sleep the evening of shot (10/23/13). Pt seems to be doing better (AM of 10/24/13) - given a steroid shot by Dr.
several hr p/vax unusually large amount of swelling;shortly thereafter devel a hive-like rash which over the next 24hrs;
pt (according to mom) became limp (dec tone) & less responsive for a few hrs; No hx of fever; dec intake; not clear if such remained strong; lasted a few hrs p/shot;
PFIZER-BIONTECH COVID-19 VACCINE EUA.  ADMINISTRATION ERROR- MIXED DOSE SERIES.  It is unclear what patient received for 1st dose of Covid-19 vaccine.  Immunization database shows patient received 1st dose of Moderna on 4/21/21.  Provider of 1st immunization is saying patient received Johnson & Johnson.  Nursing facility doctor states patient is immunocompromised and needs an additional dose.  Due to exceptional circumstances, patient cannot leave nursing facility and having trouble determining what they actually received for 1st dose.  Patient vaccinated with Pfizer on 8/26/21 for 2nd dose to complete series or provide additional dose.
12/19/21 Cough and congestion started yesterday; PT was exposed to COVID - daughter; she had COVID vaccine. She has tried Nothing, which  has not helped ROS:  Const: Fever: No, Chills: Yes, Body Aches:  Yes ENT: Ear Pain :No, Sore Throat: No, Nasal Cong: Yes Resp: Cough: Yes Wheezing No GI: Nausea:No, Vomit: No, Diarrhea:No     Neuro: Headache:   Yes
Fever, chills, nausea and vomiting this morning. Soreness of arm. Advised to please stay hydrated and drink fluids/Pedialyte to help with vomiting. Headache, fever, chills, malaise or "flu-like" symptoms are common side effects to the vaccine and should resolve in 2-4 days. Treatment of "flu-like" symptoms include common over-the-counter pain relievers/anti-fever medication such as ibuprofen, naproxen and acetaminophen (according to package instructions). See a healthcare provider if the "flu-like" symptoms last longer than 4 days.
My right arm is swollen at the injection spot. Pain and itching. Also a rash about 3 inches around injection spot.
At 1AM on 4/2/21 I had fever, muscle aches, and headache. All that day I was sick with fever, severe muscles aches, fatigue, and headache. On 4/3 I noticed pain in my right arm, a large knot/ swelling, redness, and itchiness.
Axillary lymph node swelling and pain on same side at injection site. Started at 12 hours after injection.
She got her vaccine, went home and went to bed.  She was in the bed with flu-like symptoms, exhaustion and her knees were hurting her.    Then the following week she was feeling better, but was feeling very tired and started getting brain fog.  On the third week she could not get dressed as she could no understand how to do so.  The brain fog is so severe that she has to take notes to let people know what is going on.  She has a hard time sometimes going to the bathroom from the bedroom.  She is getting better, but the brain fog remains.  She feels nauseous and does vomit at times.  She has weakness that feels like a weight that comes and goes.  Her critical thinking is not working, her problem solving is not working, and when she reads she sees the words but cannot understand what is written.  She is feeling very irritable.  She cannot understand what is happening around her.  She got lost yesterday as she could not understand where she needed to go.    She has gone to her doctor several times and has gone to the ER with this as well.  In the ER she was given steroids, which did help some.  Her doctor gives her also steroids as well.   She gave her Ivermectin for a week which helped her brain fog.  She is now antibiotics at this time, Doxycycline for Lyme infection.  They tested for Lyme disease and she was positive for this.   She is also taking Nystatin as well.   She also took steroids which was Prednisone which helped and made her feel a little better.  She also took the other medicines mentioned, and Ivermectin.   After taking that medicine the brain fog came back and she is feeling worse.    Her brain fog is so severe that she gets completely lost.  She went to the pharmacy and said that she did not know what to do as she was confused and very confused on ordinary tasks.    She has a general feeling of unwell, feels like she has a fever all the time, vision difficulties, flashes and double vision at times.  Sometimes she has speech impairment and disorientation.
Information has been received from a woman at the health department concerning an 8-year-old white female who on 13-JUL-1999 was vaccinated with a dose of Varivax. Subsequently the patient developed a rash illness on an unspecified date. It was diagnosed and reported by the patient's mother. It is uncertain if medical attention was sought. No outcome information was reported. Follow-up information from the woman at the health department indicated that she had no further information on this patient. Additional information is not expected.
Headache, pain at injection site, chills, nausea, vomiting,  body aches
In the early morning of the day after I received the Vfizer vaccination,  I developed a severe  pounding headache that lasted  two days  following this if have had many severe headaches and several dull headaches.  I I also developed severe joint pain, knees, elbows, hips, hands, pain between shoulder blades. and a sore throat. Since this time I develop hoarseness  off and on without a sore throat This has continued to the present date.  I also spike fevers out of the blue,
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 14Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Pollens" (unspecified if ongoing); "Molds" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR; ROSUVASTATIN. Past drug history included: Aspirin, reaction(s): "Known allergies: Aspirin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 26Aug2022 to 30Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the use of suspect product cannot be fully excluded.