chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness; feels unsteady at times; nearly passed out/totally passed out; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EN6198), via an unspecified route of administration, administered in Arm Left on 27Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. There were no concomitant medications. It was reported that the patient received first COVID shot Saturday. She confirms the Pfizer COVID 19 Vaccine. She says 24 hours after she had the shot she nearly passed out, she got really dizzy and someone asked, are you okay, and she said no and they caught her before she totally passed out and she sat down. She is still having waves of dizziness and she feels unsteady at times, not every second but she is a little scared to drive a car. She just thought someone should know that. It was reported that dizziness began the next day on 28Feb2021 around 3pm. She closes her eyes and says she doesn't want to look at that. It is ongoing but it is not so bad after she gets up. It seems to have lessened after about 3 pm yesterday it is bothersome. She confirms it is ongoing but improved a little since it began. The outcome of the event dizziness was recovering, while unknown for the other events was unknown.
I gave pt her flu shot at around 10:29 am (time stamp on register transaction). She also picked up a new RX which is Lithium Carbonate 300 mg. After the flu shot we discussed the Lithium briefly since it is a new medication for her. Patient was emotional and said she is depressed. She left the store. At 3:31 pm she called and asked to speak with the pharmacist. She reported pain in both of her shoulders and shoulder blades, headache, and trouble swallowing. I asked her when these adverse reactions started and she said it was 15 minutes after she left the store. I asked her if she has taken any medication since leaving  the pharmacy and she said no. I asked her if she ate anything and she said she ate some crackers. I asked her why there was a delay in reporting her symptoms and her answer was not clear. I advised her to proceed to the emergency room because having trouble swallowing is a  major concern. She said she will. I asked her to please keep in touch and I mentioned that I will file a report with VAERS.
Slushy feeling during the day; Stomach pain; Pain in throat; Aches in both arms; All joint pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Slushy feeling during the day), ABDOMINAL PAIN UPPER (Stomach pain), OROPHARYNGEAL PAIN (Pain in throat), PAIN IN EXTREMITY (Aches in both arms) and ARTHRALGIA (All joint pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0081321a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), DEXLANSOPRAZOLE (DEXILANT), PRAMIPEXOLE DIHYDROCHLORIDE (MIRAPEX), CLONAZEPAM (KLONOPIN) and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced FEELING ABNORMAL (Slushy feeling during the day), ABDOMINAL PAIN UPPER (Stomach pain), OROPHARYNGEAL PAIN (Pain in throat), PAIN IN EXTREMITY (Aches in both arms), ARTHRALGIA (All joint pain), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Slushy feeling during the day), ABDOMINAL PAIN UPPER (Stomach pain), OROPHARYNGEAL PAIN (Pain in throat), PAIN IN EXTREMITY (Aches in both arms), ARTHRALGIA (All joint pain), CHILLS (Chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102 (High) Fever of 102.         Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-066274 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Events outcome were updated from unknown to recovered/resolved.
On 2-5-04 client stated right arm really sore had a small knot as day went on went to extreme soreness in shoulders, back, arms, hips, knees, ankles, all joints.  Denies fever or N& V by 2-6-04 Left side joints fine but right side still sore and weak. To see doctor today 2-6-04
RED, SWELLING , FEVER >100 FOR SEVERal days, knot at injectoin site, dizziness , fatigue
Firmness, redness, warmth noticed during the day 04/10/2015 and still continuing up to reporting date 04/12/2015.
inadvertently vaccinated a 13 year; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently vaccinated a 13 year) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently vaccinated a 13 year). On 08-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (inadvertently vaccinated a 13 year) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Rashes all over body 1/19/2012. Seen by MD Dr. 1/20/2012 1600.
Within about 3 to 4 minutes of vaccine I experience extreme rapid heart beat that made me light headed.  I do have anxiety but I have never experienced this with my anxiety nor was I feeling anxious at the time.  It last about a minute and left, I did not experience any other reactions at the time of vaccination.   Wondering if this is normal or should I get my next vaccine in a more medical type setting?
Got his second dose few months after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got his second dose few months after the first dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got his second dose few months after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got his second dose few months after the first dose) had resolved.            No concomitant product use was provided by the reporter.   No treatment medications were reported.
Mild rash appeared on the front off my neck, not sure if it was from the vaccine, but did not have the rash prior to getting the vaccine, treated it with Benadryl itch stopping cream, which helped a lot. Rash was really itchy this morning  at 0600 am,3/26/21 but after treating with the Benadryl  it has got better, but it is still their but not as itchy. I did not think it a serious enough rash to go to the Hospital, but will go if it gets worse.
No adverse responds.  Child moved and received less than full dose:  estimated half to 90% of intended dose injected.
Pt recv vax on 11/18/98; on 11/22/98 pt exp ascending motor weakness, Guillain-Barre syndrome; pt hosp; tx=medicine
Pt got a high dose flu shot for 65 and over and PT is only 63 years of age
After the vaccine for two days I had a sore arm. In two weeks, I started seeing signs of shingles on my left arm below the triceps. I caught blister on some of my fingers. I went to see a doctor and she diagnosed with shingles. She gave me a cream to help it get better.
1542:  Pt was observed clearing throat and coughing in observation area.  Pt was offered and given water by RN.  Pt continued to cough and clear throat.  Pt also reported throat was itching, has a history of anaphylaxis and does have an epi pen, but not in her possession at this time.  Pt was unable to speak in full sentences due to cough.  Pt agreeable to transfer to procedure room for observation and vitals.  Pt denied dizziness or any other symptoms at this time.  Steady gait to procedure room noted.   1544:  Steady gait to procedure room noted.  Pt reported feeling worse than when she last used her epi pen.  Continues to cough, now dry heaving and c/o nausea, attempted to get a blood pressure, however, the monitor did not detect it possibly due to cough or movement.  Epinephrine 0.3 mg (epipen auto-injector) given IM to left vastus lateralis. Doctor is being paged by RN. 1545:  Pt reported she was starting to feel shaky.  Denies improvement in condition.  Continues to cough, c/o itchy throat and nausea.  No rash noted to extremities x 4, pt denies prutitis, no angio edema noted, breath sounds clear.  Pt's skin pink and warm.
4MAY odd sensations in hands; felt tired arm & legs hurt attributed to work, Fri-Sat to hosp via ambulance 2ndary to paralysis of legs & diff breathing; dx GBS, acute inflam demyelinating polyneuropathy progressive motor weakness
In a lot of pain; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (In a lot of pain) and HEADACHE (headaches) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (In a lot of pain) and HEADACHE (headaches). At the time of the report, PAIN (In a lot of pain) and HEADACHE (headaches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product include blood pressure medication No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23JUN2021 , contains reporter's contact information.
Case number PHEH2015US019297, is an initial spontaneous report received from a pharmacist on 28 Sep 2015. This report refers to a 12 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUCELVAX (batch number: 173991) at a dose of 0.5 ml intramuscularly 23 Sep 2015. No adverse event was reported. No further information was provided.
27 y/o female, military dependent spouse (no longer AD), calls at 16:24PM on 31 MAR 2010 with concerns re flu-like sx s/p receipt of MGC 30MAR10. "I feel like I have been hit by a truck"- headache, muscles aches, tired, warm. Patient has positive h/o petit mal seizures, rx'd with Tegretol (as child). She has seen civilian neurologist at neurology, who felt that her sx were not related to adult seizure disorder, but to "heart problem" (cardiac arrhythmia). Her PCM did not think anything was wrong with her heart. She has not been referred to Cardiology. PMH is significant for Migraine HA's and n/o positive PPD, with negative chest x-ray changes. NKDA endorsed. Patient has seasonal allergies and is allergic to bee stings. I reassured the patient that flu-like sx-HA, myalgias, malaise, fever-are listed in manufacturer's package insert form MENACTRA as systemic side effects which usually clear up within a few days. Advised patient to go to ED if side effects become severe or in event of seizure-like prodrome or loss of sensation in extremities. Notified patient, per PI that there is a potential for an increased chance of Guillian Barre syndrome following vaccination. Recommended extra strength Tylenol 500 mg po q 6h prn malaise. Patient verbalized understanding and seemed reassured by information provided.
Erythematous, warm, firm and tender plague on left anterior thigh measuring 11cm x 7 cm with satelite lesions.
Patient c/o a headache 10 min. after shot admin. Temp was taken=102 degrees. Wet cough and fever x 3 days. 11/5 developed hives, afebrile. Hives x 5 days. Hives responded to CLARITAN. Cough x 3 wks.
approx 3 days p/vax given pt cried for 3-5hr (not regular cry) cont & was inconsolable;color was pale not red as usual when crying;mom took pt to ER;
Hospitalized in May 2021 for heart issues.. EKG 3rd lead showed inverted T Wave. Nuclear Stress test and ultrasound of heart indicated oxygen deficit. (EKG prior to any vaccine was fine). Can no longer climb one flight of stairs without chest pain and shortness of breath. Newly prescribed 81mg aspirin, Metoprolol, and Prevastatin .
After MENACTRA client was "OK" then MMR, RN explained it would burn. Client said it did and approx 15 sec. client fainted - hanging over side of chair. Client did not report till after event but said he fainted twice when given blood.
Had seizure 1-2 mos. after vaccination, in another country, right side getting weaker and weaker, no fever. Diagnose with Rasmussen's encephalitis, intractable complex-partial epilepsy 2007.
This was the incorrect vaccine. The patient was supposed to receive a Tdap vaccine (Boostrix)
Taking Keflex 3000 mg and Azithromycin for an infection he had; This spontaneous case was reported by a patient and describes the occurrence of INFECTION (Taking Keflex 3000 mg and Azithromycin for an infection he had) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (Taking Keflex 3000 mg and Azithromycin for an infection he had). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) for Infection, at a dose of 3000 milligram and AZITHROMYCIN for Infection, at an unspecified dose and frequency. At the time of the report, INFECTION (Taking Keflex 3000 mg and Azithromycin for an infection he had) outcome was unknown.            No concomitant medications were reported.   Reporter did not allow further contact
On 11/10/99, pt became limp & non-responsive; was taken to ER by EMS; 15-20 min episode.
patient lied on intake form and said he had never received any moderna doses. after administration and checking cairs it shows he received in jan and feb 2021. no reaction at this time.
localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; localized injection site reaction: redness, swollen and warm to the touch; This is a spontaneous report from a contactable nurse. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 21Jan2021 at SINGLE DOSE vaccine location: left arm, dose number:1 for covid-19 immunisation. Medical history and concomitant medications were none. The patient experienced localized injection site reaction: redness, swollen and warm to the touch on 23Jan2021 with outcome of not recovered considered as important medical event. The physician recommended Tylenol and cold compress as treatment. The action taken was not applicable. Caller works in an assisted living facility.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for reported vaccination site events. 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.
Received an expired dose of Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 15th September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Sep-2022 Reporter's comment: The medical assistant reported that the patient received an expired dose of Twinrix. The vaccine was expired on 7th August 2022. There were no symptoms reported. The healthcare professional consented to follow-up via regular mail. Additional Supportive Information: The patient received expired dose of Twinrix, which led to expired vaccine used.
Shingles outbreak with numbness in right leg and top of foot, also in Aib
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EW0150) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 on unspecified date after getting the first dose of PFIZER-BIONTECH COVID-19 MRNA VACCINE. He added he has completed his 10-day quarantine yesterday. He explained that he should receive a confirmation email for the completed isolation today. He asked if he could get the second dose of the vaccine tomorrow, as initially scheduled. He then stated since a lost smell persists longer than other symptoms, is it included in the interim considerations from the CDC under their no symptoms criteria. The patient's second shot was scheduled on 27th of April. The outcome of the event was unknown.  No further information is expected; information about lot/batch number cannot be obtained.
myalgias, malaise, arthralgias, stiff hands 1 wk post vax; cont for 4 wks treated w/motrin;
Information has been received from a physician concerning a school age patient who was vaccinated with a dose of varicella virus vaccine live. "Last week", in February 2006, the patient experienced chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Had covid exposure 1/9/2021, sore throat 1/11/2021, muscle aches/chest pressure/runny nose/sore throat 1/13/2021, positive Covid test 1/13/2021.
Fever; Body aches; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Exhaustion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Amoxicillin), Allergy to antibiotic (Keflex), Allergy to antibiotic (Ceclor) and Perimenopause (take HRT). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 23-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Exhaustion). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. On 24-Jan-2021, PYREXIA (Fever), MYALGIA (Body aches) and FATIGUE (Exhaustion) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient had an antibody test- No results provided Concomitant medications included pill for menopause taken orally  Patient had her periods after taking the vaccine   This case was linked to MOD-2021-022373 (Patient Link).
It started out with headache, slight cough, felt hot, tightness in chest, and running nose. I tested positive for COVID-19 at home. Then I went to the urgent care to confirm and, I was positive. My doctor prescribed me PAXLOVID when I called. I started taking that yesterday. Today I have a sore throat and a more serious cough.
Numbness and tingling right side of tongue, numbness and tingling right lower lip and right chin.
3X8cm erythema/induration at site of KINRIX and VARIVAX injection. Treated for cellulitis with KEFLEX.
I called the patient and spoke with her on the phone on 6/14/21.  I asked if she remembered getting a shot for shingles on 6/1/21.  She did remember and reported that her arm got red and swollen and painful, that the swelling took up most of her arm and lasted for a couple of weeks.  She also reported feeling sick all over from the shot.  She was miserable she said, and reported not understanding what the shot was for, she at first thought it was for a bone spur in her heel.  Now she knows it was for shingles and asked about shingles.  I provided some education on shingles.  I explained that the reason I was calling was it came to  our attention that there might have been an error in how the shot was given, or a documentation error, and I needed her help to figure it out.  I asked her to describe where the shot was given.  She stated it was given in her right arm, straight down from the clip in her bra strap.  She could not clarify if it was down from the tip of her shoulder, but said it was about a hand width, or maybe 3 or fingers down from the clip in her bra strap.  I asked if it was in the back of her arm and she said not really, more in the middle.  I told her it may have been given in a muscle or in the subcutaneous or fatty part of her arm, I could not tell from her story.  She could not clarify.  I explained that it is best if this shot goes in a muscle, but if it goes into the subcutaneous tissue, it is still effective, so it would not have to be repeated.  I asked if this shot was her first shot for shingles, and she said yes.  I told her she only needed one more.  Patient said there was no way she was going to get the second shot after the misery this one caused. I expressed empathy for her ordeal, and invited her to discuss the pros and cons of the second shot with her provider.
Itchy, red , rash on right arm, back, and chest. Treated with Benadryl PRN. No fever, NO SOB, No swelling. No further Hep  B shots.
She started to notice increased pain and redness which has worsened through the weekend and into the following week.