chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 2-3 minutes after vaccine administration patient had vasovagal episode lasting 1-2 seconds. Came to quickly.; This is a spontaneous report from a contactable other healthcare professional. A 15-year-old non-pregnant female patient received first dose of bnt162b2 (Solution for injection, Batch/Lot Number: EW0196), intramuscular, administered in arm left on 11Jun2021 15:30 (at the age of 15-years-old) as 1st dose, single for covid-19 immunisation at doctor's office/urgent care. The patient's medical history and concomitant medications were not reported. Patient had no known drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Any other medications the patient received within 2 weeks of vaccination was unknown. On 11Jun2021 15:30, the patient experienced about 2-3 minutes after vaccine administration patient had vasovagal episode lasting 1-2 seconds, came to quickly. The reported seriousness of the event was medically significant. Patient did not receive any treatment for the event. The clinical outcome of the event was recovered on an unspecified date in Jun2021.; Sender's Comments: Based on the information provided, the causal association between the suspect drug and the event cannot be excluded. 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 as appropriate.
TREMORS AND SHAKING ON ONE SIDE OF BODY FOR LESS THAN 60 SECONDS. SHAKING EPISODES HAPPENED 3 TIMES. PATIENT DID NOT GET CYANOTIC.
as with dose 1 and 2, booster vaccine had similar side effects:  bad headache, aches/muscle pain, tendon pain in achilles, nausea, fatigue lasting 24 hrs
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 205L21B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna CoviD-19 Vaccine, Spikevax and Spikevax. Past adverse reactions to the above products included No adverse event with Moderna CoviD-19 Vaccine, Spikevax and Spikevax.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2022, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient stated that she received 4 Moderna COVID-19 vaccines. The patient had covid-19 disease from past 6 days. The patient was asked to be quarantined for 7 days and to receive the bivalent booster No treatment medications were reported.
12/5 Diarrhea for 1 week. 12/16 101 fever & pain in the right side of abdomen, rebound tenderness. Dr. did ultrasound to check appendix. Appendix was fine but found a swollen infected lymph node. Prescribed Bactrim for 10 days. 12/31 Right groin area was painfull & had a knot. Saw Dr. 1/2/10 determined 1-2 more infected lymph nodes. Prescribed Flagyl for 10 days. 1/11/10 Mom noticed bruises getting larger & darker, petechiae rash on legs that wouldn't blanche, & nose bleeds. 1/12/10 @4am contacted Dr. & was instructed to go the the ER. ER did lab work & determined Platelet levels were less than 5,000. All other levels were in the normal ranges. Referred to another hospital & was diagnoised with ITP. Patient had been health for months even years prior to the H1N1 vacine.
Ear canal pain/discomfort noticed about 1 week after my 2nd dose of Moderna COVID-19 vaccine. Cannot tolerate wearing a mask on my ears any longer after wearing a mask for almost a year. Also, my period is 3 weeks late. I'm not pregnant because I had tubal clamping on 6/8/2015.
about 8 hours  after the first dose of the vaccine patient reports burning sensation in both feet and hands - patient reports neuropathies continued throughout the night and reported difficulty sleeping.  Last approximately 20 hours.
60mm circle around the injection site. Hard warm/hot bump. Stiff and very tender, itchy, very uncomfortable. Took Tylenol and Benedryl and my Alegra for the itching. Went back to the cllinic to see what was going on and was told I was having a reaction to the injection. Today is the 15th and I still have the itching and tenderness, but the redness seems to be going away.
My heart felt like was different my blood pressure was low and my pulse was 168 BPM. I use an electronic measuring device. I did not feel like I was going to faint but then this event lasted for one half hour so in the afternoon, I went to my family Physician so he suggested I go to the ER at the Hospital. I went and was checked out, one month later I had a similar episode and in May 2023 I had another episode again. I had this happen three times JAN2023, 06FEB2023, and MAY2023.
mom states pt exp weird cry & temp immed p/vax; pt also exp weird cry w/ dose 1 of DTP
Pt stated she felt dixxy after receiving the vaccine. BP: 102/68 02: 100% HR:88
Patient described not being able to lift her arm above her shoulder since vaccination. She stated it has improved since vaccination date.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A more than 65 (unit unspecified) patient of unspecified ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced welt under the skin on an unspecified date. Outcome of the event was unknown.
This case was reported by a consumer (the subject's grandmother), via another manufacturer (Merck), and described the occurrence of leg rash in a female subject of unspecified age who was vaccinated with DTAP vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of DTAP vaccine (details unknown). In August 2010, at an unspecified time after vaccination with DTAP vaccine, the subject experienced rash on her legs and injection site rash. The subject was taken to an allergist and unspecified tests were performed with unspecified results. At the time of reporting the outcome of the events was unspecified. The consumer reported that "while on" DTAP vaccination, in August 2010 her granddaughter experienced a rash on her legs and near the injection site.
big, very itchy rash, sensitive to touch; red blotch ~2.5 inches in diameter; right leg muscles extremely uncomfortable; sore arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm of injection site), VACCINATION SITE RASH (big, very itchy rash, sensitive to touch), VACCINATION SITE ERYTHEMA (red blotch ~2.5 inches in diameter) and MUSCLE DISORDER (right leg muscles extremely uncomfortable) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included OSPEMIFENE (OSPHENA) for an unknown indication.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm of injection site) and MUSCLE DISORDER (right leg muscles extremely uncomfortable). On 09-Feb-2021, the patient experienced VACCINATION SITE RASH (big, very itchy rash, sensitive to touch) and VACCINATION SITE ERYTHEMA (red blotch ~2.5 inches in diameter). At the time of the report, VACCINATION SITE PAIN (sore arm of injection site), VACCINATION SITE RASH (big, very itchy rash, sensitive to touch), VACCINATION SITE ERYTHEMA (red blotch ~2.5 inches in diameter) and MUSCLE DISORDER (right leg muscles extremely uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drugs included Topical anti-itch cream, as needed.
Patient was fine after receiving vaccine 15 to 20 minutes later after leaving vaccination room, she stopped and bent down to pick up a book in the aisle. She glanced through the book, put it down and proceeded to leave the store. Suddenly an excruciating pain down her back and she cannot move. She proceeded back toward the pharmacy and Pharmacist and intern pharmacist helped Patient into the clinic room and sat down with her. After 15 to 20 minutes, patient felt better and called for ride home. On 3/2/20 around 8pm, I called to check-in on patient. She had been using ice and hot pads rotating every 20 minutes and is feeling less pain. I urged patient to see her PCP. Today, 3/3/20 patient returned to pharmacy to pick-up Prednisone in which PCP had prescribed and patient stated PCP said her had allergic reaction to vaccine and to also take some Benadryl. The site of injection looked swollen and warm to touch. Patient also saw chiropractor and said back was feeling better but her arm is sore.
Patient received Pfizer Vaccine (Lot # EP7534 Exp: 3/20/2021) @ 12:48 PM on left deltoid. Prior to vaccination, patient stated to RN vaccinator, I feel anxious with needles. RN approached patient calmly and explained risks/benefits of vaccine. RN received verbal consent to give vaccine to patient. At 1300, patient at EMT station complaining of lightheadness, tingling in the mouth, and stated feeling anxious. Past medical history includes auto immune disease. No history of severe allergic reactions. Patient reported that she ate 3 hours ago. EMT noticed flushing of the face. At 1305, patient laid down in recliner chair and water offered. Vital signs taken every 5 mins. Patient alert and oriented x3. At 1310, BP 137/95, P 96 strong, RR 16 unlabored. At 1323: BP 138/100, HR 92 thready, RR 12. Upon assessment, skin warm to touch and normal skin color, damp palm, shaky arms and legs. Patient says "it feels like previous panic attack", and reports tingling in the mouth improved. At 1325, RN offered EMS to patient but patient declined. Vitals at 1330: BP 130/90, P 84 thready, RR 14. At 1335: BP 130/90 P 86 strong RR 14. At 1342: BP 120/80, P 80, RR 12. At 1337, 100 ml juice given and patient contacted her boyfriend to pick her up. At 1357, patient left the facility without assistance and with a steady gait.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improperly stored VAQTA pediatric (25/0.5 unit unknown, lot# L023232, expiration date 25-FEB-2017, route not reported). The vaccine was improperly stored in 12 Celsius degree for 8 hours and 23 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported. Additional information has been requested.
Large local swelling and hives on legs, buttocks, face. No difficulty breathing or facial swelling. Sxs started after 24 hours.
Rash developed on both forearms, groin areas and thighs bilaterally. We suggested that he take Claritin, which he did for 2 days, then rash was completely gone.
SWELLING, REDNESS, PAIN AT INJECTION SITE.  DOCTOR INFORMED PATIENT THAT IT WAS CELLULITIS AND TO TAKE BENADRYL AND IBUPROFEN ALONG WITH COLD COMPRESSES.
2/2/2022 Row - TAV           Diagnosed with COVID today- started with symptoms           yesterday including            cough, headache, temperature to 100.0F           Denies shortness of breath           Covid, advised on supportive care monitoring           symptomsPurchase a pulse oximeter and to contact           us if below 94%, and also if            shortness of breath or high fevers
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a  healthcare professional regarding a  patient who experienced cry so much and vaccine cause much discomfort. The patient received a  dose on an unspecified date. Event details, the nurse reported that regardless of lot number and injection technique, when babies are administered  Prevnar in her office they cry more, and experience much discomfort. No additional information was available at the time of this report. Manufacturer Comments: The reporter was unable to specify the number of pt;s who experienced the events. Additional reports will be generated when identifying information is received.
72 y.o. female with head and neck squamous cell carcinoma admitted to the hospital for left-sided weakness   LDL 132 Potassium 3.1 MRI brain showed acute to subacute right parietal and right frontal lobe infarct. CTA head and neck showed no significant stenosis HbA1c 5.2
Rash & swelling to RD  tx with decadron injection & cool pack Mother reports pt received influenza vaccine last year too which caused his arm to be red & swollen took pt to Urgent Care was given steroid injection & rocephin thought it may have been a skin infection, but it was 48 hrs post injection. Influenza Pf 6mo+ given IM in LD Lot 425T2 NDC 58160-896-52 10/10/19.
Almost 3 1/2 weeks later broke out all over with red body rash.  It is very itchy.  Took two benedryl just now.
pt recvd vax; 4 inch area of erythema & edema at inject site; minimal tenderness; tx cold pack  application & advil;
"COVID Arm," bright red rash, bruising at injection site, shakes, chills, fever, vomiting for nearly 36 hours
pt felt hot, t104, did not feel well, t104, spots on face arm & legs got progressively worse;eyes red-body limp;flat pinkish red spots;
Very sore arm, from site of injection to below elbow lasting more than 24 hours.  Extreme fatigue for 24 hours.
PATIENT REPORTED EXPERIENCING TINNITUS ("HUMMING IN THE EARS") FOR BOTH EARS. WENT TO SEE HE ENT MD AND WAS INFORMED THAT PATIENT MIGHT BE EXPERIENCING THIS AS A SIDE EFFECT OF COVID VACCINES. PT RECEIVED LAST PFIZER VACCINE ON 07/25/22. REPORTED TO HAVE STARTED EXPERIENCING TINNITUS AROUND 11/2022,  SAW THE HE ENT DOCTOR AROUND 12/2022. PATIENT CLAIMED SHE HAS NEVER EXPERIENCED THIS REACTION WITH ANY OF HER PREVIOUS COVID SHOTS.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
lymph nodes swollen under left arm to middle of chest; Dose 3; Caller reports having had episodes of bronchitis where the doctor checks his lymph nodes before but says a swollen arm pit, never had happen to me before; Caller reports having had episodes of bronchitis where the doctor checks his lymph nodes before but says a swollen arm pit, never had happen to me before; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): -PFIZER INC-202101572685 (PFIZER).  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 14:00 (Lot number: FE3592, Expiration Date: 30Nov2021) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma, diagnosed since he was a kid. Concomitant medication(s) included: SINGULAIR taken for asthma. Vaccination history included: Bnt162b2 (Dose 1, Lot: EN6205, Expiration: 30Jun2021), administration date: 09Mar2021, when the patient was 46 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Lot: ER2613, Expiration: 31Jul2021), administration date: 30Mar2021, when the patient was 46 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021 14:00, outcome "unknown", described as "Dose 3"; LYMPHADENOPATHY (non-serious) with onset 11Nov2021, outcome "not recovered", described as "lymph nodes swollen under left arm to middle of chest"; BRONCHITIS (non-serious), SWELLING (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Caller reports having had episodes of bronchitis where the doctor checks his lymph nodes before but says a swollen arm pit, never had happen to me before".  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. No AEs following prior vaccinations. The events did not result in emergency room or physician office visit. The reporter assessed the events as non serious. No other vaccines was administered on same day as suspect.  Follow-up attempts are completed. No further information is expected.
About two minutes after she received her shot she told us she was seeing black spots. Then she told me she couldn?t see and she passed out. She started to regain consciousness and a little bit of blurred vision and then she began dry heaving. She was clammy and sweaty at that point but continued to improve after she drank some water.
Next day after vaccination I could barely stand up because of intense dizziness. Checked my blood pressure and was 148/98. Never in my life I had a blood pressure over 110/70. It took almost two weeks to get to 128/78 (which is still higher then usual.
Rapid onset of flu symptoms ( chills, fatigue, mild dehydration, fever , 102.5 F temp at 6:30pm 10/10/2005. Spiked pm on 10/11/2005. Asymptomatic on 10/12/2005. Reaction not observed by health center.
High fever, fussiness, rash, not acting herself. Received MMR#1, varicella #1, PCV13#4 on 2/18/14. On 3/1 fever, rash. Completely better 3/10/15.
High Fever. "Mild" seizures off and on for months where he would zone out and shake all over them scream after the shacking stopped Regressed by forgetting how to laugh and smile.
FATIGUE; trembling; Skin pain; CHILLS/teeth chattering; SKIN SENSITIVITY; NAUSEA; HEADACHE; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (6 months back 1st dose received. Please refer the case US2020092731).   On 1st June 2020, the patient received the 2nd dose of Shingrix. On 1st June 2020, 9 hrs after receiving Shingrix, the patient experienced chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain. In June 2020, the outcome of the sensitive skin was recovered/resolved. On an unknown date, the outcome of the chills, nausea, headache, tremor and skin pain were recovered/resolved and the outcome of the fatigue was recovering/resolving.   It was unknown if the reporter considered the chills, sensitive skin, nausea, headache, fatigue, tremor and skin pain to be related to Shingrix.  Additional details were provided as follows: On 1st June 2020, the patient received 2nd dose of Shingrix. 9 hour after receiving the vaccine the patient experienced the patient described the skin sensitivity as pain on her skin all over the skin was sensitive to the touch, the chills were described as trembling and teeth chattering. The fatigue was better but still present at the time of this report.  The events were lasted approximately 8 hours.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020092731:dose #1
flu-like later that night,similar to the mild flu, but; achy that night; real tired for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like later that night,similar to the mild flu, but), PAIN (achy that night) and FATIGUE (real tired for 3 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 11-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like later that night,similar to the mild flu, but), PAIN (achy that night) and FATIGUE (real tired for 3 days). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like later that night,similar to the mild flu, but), PAIN (achy that night) and FATIGUE (real tired for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided. Med info agent: Caller states that after second dose patient was more tired and achy that night, but the next day was okay.  Consent to follow-up from safety team if needed. Caller provide name of vaccination  facility and name of health care provider.   This case was linked to MOD-2021-237320 (Patient Link).
After giving patient the shot, a few minutes after she felt like she was going to pass out. Per mom who was with patient, patient passed out for a few seconds. I ran to the patient, who was pale but alert and oriented.
1st 15 minutes feeling flush. 15-25 minutes tickling in the throat. After 1 hour patient was feeling better (when home by himself & went to work next day).
Received vaccine 2/3/21. On 2/5/21 began experiencing tightness in chest, short of breath. At first not really noticeable, but increasingly problematic until I went to urgent care on 2/7.  The NP said there was definitely wheezing and tightness. Decreased peak flow on incentive spirometer.  Treated with budesonide and formoterole fumarate inhaler for 4 weeks.     this is not the first time that I have had an exacerbation, but usually there is a trigger (extremely poor air quality,  other illness).  The only thing that I can attribute this exacerbation to is the vaccine.