chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started having mild on paying around 1:00 AM. I woke up and took some Tylenol. I 24 hours after getting the injection I had flu like symptoms. 48 hours after the injection I was dizzy and a little confused. I took a couple of Benadryl and intermittently traded my owl just with Tylenol. I drink a lot of fluids and Gatorade to try to remain hydrated and rested as much as I could. I woke up on 12/25/20 and felt a little better. That evening, I started feeling a little confused but was tired from playing with my kids and their new toys at Christmas. Tell my husband I was just going to go to bed. I woke up on 1226, covered in sweat and had difficulty ambulating informing my words. I was concerned I may have had a stroke. I didn?t recognize my children and couldn?t recall their names. I went to the emergency room and was told this 100% could NOT be a vaccine reaction and I was withdrawing from adderall. I take a 10 mg dose daily and it?s not uncommon for me to skip that for weeks at a time, I tried to explain that but again, nobody was allowed to come in the facility with me and I was having difficulty speaking. My blood pressure was 190s/89 ish and they did a ct of my head that was overall, unimpressive and clear. The reaction ended with me having Bell?s palsy approximately 10 days after the vaccine and on the same side I received my injection in.  In between onset of sx. And the Bell?s palsy, my lips would go numb, intermittently and sometimes my right arm and right leg would turn inward, intermittently (like decorticating posturing).
Shortly after booster shot, I got swelling and pain in both feet. The swelling and pain have continued for more than three months. The swelling varies, but worsens during the day and has been somewhat controlled with ics packs andhas now moved up the lower legs to the knees. The pain moves around and has lessen somewhat, but still remains after more than three months. My walking has been severly impaired. I have had three rounds of Prednisone and Injection of a Steriod in my left ankle.
At the end of 15min. Observation period client fainted in his chair. Blood pressure dropped  to 90/40 pulse 44. He awoke within a minute and drank to cups of water. Blood pressure resumed to normal 122/54 pulse 56.  He had a very physical day at work, no food all day, maybe not to much water.  Pt left stating he felt fine enough to leave and drive home.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 25-SEP-2018, the patient was vaccinated with a dose of M-M-R II (Albumin status, rHA), intramuscularly; the valid lot number was R000555, with an expiration date of 01-JAN-2020, (unknown dose, and strength) for prophylaxis. And the vaccine was reconstituted with the sterile diluent (manufacturer unknown). The pharmacist reported that the patient received the M-M-R II via intramuscular route instead of subcutaneous (incorrect route of drug administration). No adverse effects reported. No further information was provided.
Sudden symptoms, flushing,palpitations,dizziness, lightheaded, vitals taken, patient expressed to be severely allergic to bees and had to uses epi-pen in the past. Epinephrine was given , ambulance was called, patient was alert and communicating through the whole incident. Ambulance arrived and upon examination, patient declined to go via ambulance and was pick up up by husband . Patient advised if continue to have symptoms to go to nearest ER.
Experiencing mild flu-like symptoms; Chills; muscle aches; slight fever; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 42-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Batch/Lot number, Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient stated, I had my 2nd COVID vaccine shot yesterday at 10am. On an unspecified date experiencing mild flu-like symptoms, chills, muscle aches, slight fever. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hot to touch; Itching on her arm; Area near injection site was swollen ( Swollen arm); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch), PRURITUS (Itching on her arm) and VACCINATION SITE SWELLING (Area near injection site was swollen ( Swollen arm)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, CALCIUM CITRATE MALATE;MAGNESIUM CITRATE MALATE, VITAMIN D [VITAMIN D NOS] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch), PRURITUS (Itching on her arm) and VACCINATION SITE SWELLING (Area near injection site was swollen ( Swollen arm)). On 27-Feb-2021, PRURITUS (Itching on her arm) and VACCINATION SITE SWELLING (Area near injection site was swollen ( Swollen arm)) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to touch) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Levothyroxine for thyroix, Calcium citrate magnesium for bone strength, Vitamin D for supports bone strength and multivitamin for dietary supplement is the indication for use for concomitant medications Treatment details included antihistamine.   This case was linked to MOD-2021-096600 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Feb-2021: Follow-up was received on 28-APR-2021 which updated patient demographics, medical history, 2nd dose details updated and concomitant medications, treatment medication and update the out come for events  swollen arm and itchy was recovered.
COVID-19; Shingles; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), COVID-19 (COVID-19) and RASH (Rash) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025L202A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (Had gotten higher) and Hyperlipidemia. Concomitant products included PRAVASTATIN for Hyperlipidaemia, LOSARTAN POTASSIUM (LOSARTIN), MELOXICAM, VITAMINS NOS, FISH OIL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and CARVEDILOL for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced RASH (Rash). On 13-Jan-2021, the patient experienced HERPES ZOSTER (Shingles). On 19-Jul-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, HERPES ZOSTER (Shingles) and RASH (Rash) had resolved and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive, Type of test - saliva..         No treatment information were reported.  Action taken with the drug in response to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29 Jul 2021 includes new concomitant medication, one event of COVID-19 and lab data updated
I experienced an extreme head pain/headache that was located on the top of my head. This pain felt between a horrible migraine headache and as if I was hit by a baseball bat. The pain woke me out of my sleep and kept me awake for at least an hour+. (approx 2:30am-4:00am). When I woke up a couple hours later the intensity had gone down and I went to work. As time passed, the pain/discomfort dulled and by midafternoon I was barely able to notice it (I had to focus on it).
Generalized urticaria noted approximately 7 hours following MCV4 and Tdap. BENADRYL, Prednisone given.
Heart/chest pain, sharp pain, discomfort  (ongoing daily-progressing) Headache, head swelling feeling (ongoing daily)
On 11/2/18 at 11:05am, pt's wife called pharmacy to let us know that pt developed cellulitis after receiving PNEUMOVAX 23. Vaccine was given on 10/25/18 at 3:30pm. pt received antibiotics on 10/31/18. Wife did not say pt was having any other side effects from vaccine.
A report has been received from a Health Professional concerning a 4 year old, male subject, who had been receiving FLUMIST, 0.2 Millilitres, unknown. Vaccine given within prior 4 weeks included influenza vaccine. FLUMIST started on 23-Dec-2015. It was reported that a 4-year-old child who previously received a flu shot on 08-Dec-2015 was given FLUMIST on 23-Dec-2015. FLUMIST was discontinued on 23-Dec-2015. The outcome of the event of FLUMIST two weeks later after flu shot is unknown. The reporter's description of the event was as follows: none. The report was considered to be non-serious.
5 mins after the shot I felt light headed, nauseated, weak in the knees. I drank water and tried to eat a small snack. I started getting really cold and began shivering and had GI discomfort. At the 20+ minute mark I went to get the nurse. She returned with BP cuff and pulse ox, BP was elevated as was pulse. I continued to have waves of feeling weak, shaky and sick but nurse said I should go home an lie down at the hour mark. Once home my throat felt really dry and strange, I had a BM, laid in bed about 20 more minutes and decide decided I wanted to get check out. Went to ER and was seen ~3 hours after vaccine. BP and heart rate were still both up. I still felt nauseated, dizzy and cold. I was given Meclizine and Zofran. BP retuned closer to normal after about 40 mins and I was released, feeling better but fatigued.
I had fever, chill, body ache, sore throat, congestive, cough and headache.  These lasted for about 5 days.  On Jan 17th, I was tested positive for Covid-19 test.
Chest tightness; throat itching; light headed; coughing; chills; muscle aches; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207), via an unspecified route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, Hashimoto's disease, diabetes type 2 and hypertension. Concomitant medications included levothyroxine 125 mcg (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN) and paroxetine (MANUFACTURER UNKNOWN), all for unknown indications from unknown dates. The patient previously received lisinopril (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Marr2021 at 14:15, the patient experienced chest tightness, throat itching, light headed, coughing, chills and muscle aches. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events chest tightness, throat itching, light headed, coughing, chills and muscle aches. The clinical outcomes of the events chest tightness, throat itching, light headed, coughing, chills and muscle aches were not recovered.   No follow-up attempts are needed. No further information is expected.
Does not have an appetite; Lymph node is sore; Arm pit was swollen; Arm hurts; Headache that went around the whole head; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Does not have an appetite), LYMPH NODE PAIN (Lymph node is sore), LYMPHADENOPATHY (Arm pit was swollen), VACCINATION SITE PAIN (Arm hurts) and HEADACHE (Headache that went around the whole head) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included OMEPRAZOLE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced HEADACHE (Headache that went around the whole head). On 08-Jan-2021, the patient experienced DECREASED APPETITE (Does not have an appetite), LYMPH NODE PAIN (Lymph node is sore), LYMPHADENOPATHY (Arm pit was swollen) and VACCINATION SITE PAIN (Arm hurts). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (Does not have an appetite), LYMPH NODE PAIN (Lymph node is sore), LYMPHADENOPATHY (Arm pit was swollen), VACCINATION SITE PAIN (Arm hurts) and HEADACHE (Headache that went around the whole head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Janssen COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Received Janssen Vaccine on 3/8/21. Covid + 1/22/22. Presented to ED on 1/24/22 w/cough and SOB, admitted for acute hypoxemic resp failure 2/2 Covid PNA. Pulse ox on room air 78 %, w/Airvo nasal cannula O2 sats 94%. Noted to be hyperglymic on admission, new dx T2DM this admission. Intubated on 2/3 due to refractory ARDS. CXR revealed large chest wall ongoing severe bilateral infiltrates. Continued to declined, transitioned to DNR. Treated with tocilizumab, remdesivir, dexamethasone, zosyn and solumedrol. Expired 02/08/22.
I am experiencing a lot of itchiness after getting the second dose of the Pfizer; This is a spontaneous report from a contactable consumer reported for self. A patient of unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number& Expiry date not reported) via unspecified route of administration on unspecified date as dose 2, single for COVID-19 Immunization. Patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number& Expiry date not reported) via unspecified route of administration on unspecified date as dose 1, single for COVID-19 Immunization. Patient had no reaction on previous exposure to drug. On unspecified date, Consumer stated the concern, the patient experienced a lot of itchiness after getting the second dose of the Pfizer and wondered like is that normal or at a certain point is there something you guys are supposed to do about it. Consumer was informed about the role of Pfizer Drug Safety and also informed that for the question Pfizer Medical Information is the right department to answer the question. The clinical outcome of event was unknown.  Follow-up attempts are needed; information about lot/batch number has been requested.  Follow-up (29Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upon waking up felt cold sweat, nauseated and became dizzy. Within 5 min from leaving the bed I lost consciousness for 2-3minutes. Next thing I remember being on the kitchen floor being called by name by my wife, w a sharp pain on back of my skull. Was told I suddenly collapsed onto the floor. I trained to stand up but could not maintain posture. Had to lay down on my left side for 15-20 min. Then I was able to drink water and walk back to bed where I remained for next couple hours.
Patient came in and received first dose of Covid Moderna injection to left arm at approximately 8:45AM.   Patient then ambulated to observation area where approximately 5 minutes later she reported feeling faint and as if she was going to pass out.   Observation nurse  approached patient.  Two additional RNs on site, came to patient's side; first, RN second, RN.   Pulse oximeter was placed on patient's left index finger, which read 99% O2 on room air and HR of 88.  Patient reported history of anxiety.   Stroke assessment was negative.   Paramedics were called.        Patient remained conscious and oriented.   Patient was instructed to perform deep breathing exercises.  Paramedics arrived at approximately 9:05AM.    Patient was assessed by paramedics and placed on gurney.   Patient was alert and oriented upon departure  and patient was transported to nearest hospital.
Initial report received on 30 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3428AB received on 07 October 2009, lot number C3470AA received on 15 December 2009, lot number C3573AB received on 17 February 2010 and one dose of DAPTACEL, lot number C3473AA received on 06 January 2011 (routes and sites of administration not reported). The subject developed cold-like symptoms on 19 June 2012, approximately 17 months after the last dose. On 26 June 2012, the subject developed a cough. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 28 June 2012 for five days. The subject was not hospitalized. At the time of final contact on 26 July 2012, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. According to the investigator, this case was epidemiological linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Information has been received from a health care facility concerning a patient who was vaccinated with a first and second dose of varicella virus vaccine live on 01/19/2000 and 03/13/2000, respectively. Concomitant vaccinations included a 4th dose of hepatitis B vaccine on 01/05/2000. TB skin tests performed on 01/05/2000 and 03/28/2000 were negative. On 04/28/2000 the patient's diagnostic lab tests indicated that the varicella zoster IgC and rubella titer were negative. Additional information has been requested.
mom called routine APAP given 2PM-6PM;  pt crying, t104.6; cried off & on until 4AM; vomit & shook through noc; 20AUG AM afebrile cranky;
Itchy left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy left injection site arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy left injection site arm). At the time of the report, VACCINATION SITE PRURITUS (Itchy left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant product use was provided by the reporter.  No treatment medication was provided.   This case was linked to MOD-2021-303330 (Patient Link).
Pt presented w/ slight erythema on left arm 5 days after receiving injections. She insisted on having both shots in same arm due to previous surgery on other side of body. Said area was warm earlier in week, MD told her to take BENADRYL.
Within 5 minutes of receiving vaccine he complained of itchy tongue and mouth followed by red face extending to his arms and torso. He was given Benadryl but when tiny urticaria and face swelling increased he was given SQ epinephrine.  He relapsed 1 hour later including a hoarse voice which responded to repeat epinephrine. Discharge Summary received on 3/10/2004 states allergic reaction.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/27/2021 and 3/20/2021. Presented to ED on 8/17 with complaints of shortness of breath x1 week, diarrhea, light-headedness, headache, and right lower extremity swelling. Patient was placed on supplemental oxygen and admitted. On 8/18 patient exhibited facial droop and left arm/leg weakness. CTA revealed right ICA occlusion and underwent thrombectomy and stenting. ICU, patient had persistent L-sided deficits with concern for devastating neurologic injury. On 08/19, patient was found to have new R pupillary dilation and repeat CTA & CTH revealed re-occlusion of R ICA & R M1 occlusion and petechial hemorrhage. Per Neuro IR, patient not a candidate for repeat MT. Patient was managed with 3% saline and blood pressure control with Cardene gtt with permissive parameters.  On 08/21, the patient became hypoxic with increased work of breathing. CXR revealed stable chest and she was placed on HFNC. She was also found to have oliguric AKI in the setting of contrast nephropathy and loss of renal autoregulation in the setting of acute stroke. Nephrology was consulted and discussed with family.  Patient's family decided to transition to comfort care measures and withdraw life-sustaining treatment.  On 8/22/2021, the patient was pronounced deceased. For COVID, Patient was treated with Remdesivir, Acyclovir, Dexamethasone.