chrisvoncsefalvay/vaers-outcomes huggingface dataset:
23Feb2020 tingling thru out mouth and tongue, thick tongue, film back of throat; red rash on both forearms/rash on forearms, inner thighs; numbness on nose and cheeks next to nose/numbness on lips and bridge of nose/cheeks; rash with pain on forearms; This is a spontaneous report from a contactable other-healthcare professional. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: E19261), via an unspecified route of administration, administered in arm left on 10Feb2021 at 13:45, as single dose for covid-19 immunization. Medical history included atrial fibrillation (Afib)/pacemaker (have duel chamber pacemaker), flax seed allergy and some antibiotics allergy. Concomitant medication's included dronedarone hydrochloride (MULTAQ), metoprolol succinate, apixaban (ELIQUIS) and alprazolam (XANAX). The patient previously took celebrex and cephalexin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Feb2021 at 02:15 patient experienced, rash on forearms, inner thighs, numbness on nose and cheeks next to nose, rash with pain on forearms, numbness on lips and bridge of nose/cheeks rash on inner thighs. On 23Feb2020 she experienced tingling thru out mouth and tongue, thick tongue, film back of throat, lips and bridge of nose/cheeks numb. AE resulted in Doctor or other healthcare professional office/clinic visit. As treatment she received antihistamine. Outcome was resolving for red rash on both forearms/rash on forearms, inner thighs and numbness on nose and cheeks next to nose/numbness on lips and bridge of nose/cheeks and other events were resolved on an unknown date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Chills, muscle weakness, body aches, fever, soreness at injection site, headache and nausea reported by patient.  Onset of S/S 24 hours after administration per patient evaluated at Urgent care clinic on 7-25-09.
Child's reaction included fever of 100F and approximately 15 hours after receiving his vaccines he suddenly began to have edema of the face, throat, eyes, mouth and dry cough. He was taken to urgent care and treated with oral steroids and Benadryl.  They think it is related to the vaccines. He responded well to the treatment and is doing ok as of today.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 08-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N020352 and expiration date 10-APR-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709:
It started with a drainage in the back of my throat. It lasted for two weeks. I then had body aches and started having drainage in my nose. Then I figured it was not allergies. I bought a COVID-19 at home test, and it was positive. I called my PCP, and she said I was too late to receive the COVID-19 medication. The body aches started in weird places, it was in my neck and joints. I even felt the aches in my feet and toes. I have never experienced anything like that. Today my nose is still drippy, and I have more energy, I feel better in the morning than the evening. The body aches is not really there. I do have a cough now that is dry, and I have been sneezing more.
Red, hot area at injection site. 2.5" wide & 3.5" long. Tender to touch. Not itchy.
This spontaneous report as received from a pharmacy student refers to a patient of unknown age and gender. The patient's pertinent medical history was not provided. On an unknown dates, the patient was vaccinated with RECOMBIVAX HB series twice (dose, frequency, route of administration, lot # and expiration date were not provided) and the patient non responded to RECOMBIVAX HB. The outcome of the event was unknown. The relatedness between the event and vaccination with RECOMBIVAX HB was unknown. Additional information is not expected because the reporter declined to participate in this report.
Pt started feeling tingling in lips and around eyes and anxiety about 15 minutes after receiving her 2nd covid vaccine. She had immediate local swelling, itchy eyes, nasal congestion, and angioedema.
Pt completed SMALLPOX vaccination screening form, marked "NO" to #9 (Could YOU or someone you LIVE WITH be pregnant?), as well as "FOR FEMALES ONLY" If you might be pregnant, or likely to become pregnant, please tell us. You may need additional pregnancy testing. 18a. First day of last menstrual period (2018/03/25) 18b. Was your last menstrual period normal and on time? "YES".  Following vaccination earlier in the day, pt proceeded to take a home pregnancy test, which was positive, then reported to the Medical Center ER for confirmation, which was positive. ER referred pt to OB the following day for further evaluation and care. Unclear dates of pregnancy (pt reported on screening questionnaire 3/25/2018 at LMP, but reported "2 weeks ago" to the ER). Other information regarding pregnancy are not available at this time, pt will be following up closely with OB.
within 30 mins of vaccination, patient collapsed due to profound left upper and lower extremity weakness consistent with new CVA.  She was transported via EMS  where she was admitted for new CVA and underwent mechanical thrombectomy and IA infusion of nonthrombolytics of right ACA A2-A3 junction.  Successful recanalization.
Severe body chills and aches, extreme sweating, 104 degree F fever for 12 hours.  Rash on arm. After all of this subsided, blurred vison. my vision has been quite blurry since receiving the vaccine.
I was on a vacation for a week ending on 12/3/22 and my roommate had a cough and runny nose, I didn't feel anything but was likely primed for whatever he had. The illness I have had from 12/5-12/8 has been the worst experience of my life. At one point a solid 10, currently a 5. Liquid from both ends. Couldn't keep food in. 101.7 fever for 2 days, hot sweats, terrible productive coughing to the point of pain. Several vomiting sessions mid sleep. The roommate has recovered and had none of the symptoms I did. 2 other people I have infected (my spouse and another guy) also did not have the extreme symptoms I did. I received my flu vaccine in September.
The patient experienced a large local allergic reaction from the injection site in the left deltoid to mid forearm with erythema and swelling. The symptoms were similar to bee sting reaction.
Soreness; Injection site feels warm to the touch; Injection site is swollen; Injection site is painful; He cannot move his hand all the way up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), INJECTION SITE WARMTH (Injection site feels warm to the touch), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PAIN (Injection site is painful) and MUSCULAR WEAKNESS (He cannot move his hand all the way up) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (Soreness), INJECTION SITE WARMTH (Injection site feels warm to the touch), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PAIN (Injection site is painful) and MUSCULAR WEAKNESS (He cannot move his hand all the way up). At the time of the report, PAIN (Soreness), INJECTION SITE WARMTH (Injection site feels warm to the touch), INJECTION SITE SWELLING (Injection site is swollen), INJECTION SITE PAIN (Injection site is painful) and MUSCULAR WEAKNESS (He cannot move his hand all the way up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided; 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.
Psoriasis outbreak on soles of  feet and palms of hands ,never before have I had psoriasis .
The day following vaccination, reactions included extremely sore and bruised injection site, muscle and joint pain, chills, fatigue, and itching on soles of feet and palms of hands. These all passed in three days. No reactions since then until today, March 17. Now I have hives near injection site that are itchy, raised, and red. This is 13 days post vaccination #1.
Chills,Lightheaded, Nauseated, Left leg pain and body aches.
pt recvd 2nd Hep B inj-pt exp numbness, tingling down lt arm w/marked weakness per MD; MD recommends pt not receive 3rd inj in series; also had severe h/a w/vomiting p/1st;
Headache & Myalgia Narrative: Muscle aches Sensitive skin Headache
I am a healthcare provider. I had prophylactically premedicated with Tylenol prior to receiving my covid-19 vaccine. Immediately following the vaccine I had mild / moderate pain at injection site and muscle soreness at injection site. Roughly 20-24 hours after receiving  the vaccine, I developed moderate headache, fatigue, fogginess, full body aches, nausea and upset stomach. I continued on Tylenol twice daily. After a good night?s sleep, I felt better the following morning and all symptoms had resolved within 48 hours post vaccination.
- Pain, redness, swelling where the shot was given.  Very painful.   Unable to move my arm most of Sunday. - Hot and cold chills. - Numbness in fingers and toes. - Dizzyness, lightheaded, faint.   - Confusion and anxiety. - Headache. - Fever 101 from Saturday night until Sunday at 3:00 until I took Aleve.   99.1 fever returned this morning. - Feeling very tired and weak. I have been in bed all day Sunday and Monday.  - Muscle pain.  My whole body hurts. - I will never take this vaccine again. It seems my body is attacking this vaccine.    My body does not like this vaccine.
Neck ache right away after injection. Next morning I had swelling in lymph nodes under my armpits on both sides. My left side was more swollen. I also had fatigue for 3 days.
Took all three Covid vaccine; I just had a positive test this morning; Took all three Covid vaccine; I just had a positive test this morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EL3248), in left arm, on 24Mar2021 as dose 2, single (Lot number: 3248), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: EW0196) at the age of 40 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Celiac disease" (unspecified if ongoing). Concomitant medication(s) included: FLUVOXAMINE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Jun2022, outcome "unknown" and all described as "Took all three Covid vaccine; I just had a positive test this morning". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Jun2022) Positive; Weight: (unspecified date) I do not know may be 145. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: This is the first case of the 2 split cases. NDC number of Covid Vaccine was unknown. The patient was taking other products. Call was from Pfizer employee and was reporting for herself. Consumer (Pfizer employee) stated, "She has a couple of adverse events to report. We just have name of things if you took the Pfizer vaccine and then experience the Covid infection, that should be reported. So, she does guess the product here would be the vaccine. So that was, that one is for her. And she was looking for to report from this morning. So that's her adverse event." When probed for another adverse event and product: Consumer stated, "The second one is for her dad (split made). So, he took Paxlovid. She didn't know if she reports it to Drug Safety or talk with the RA Drug Safety". Consumer was told about the role of Pfizer Drug Safety. Consumer stated, "The second dose said lot number 3248. That one didn't say EL, that was just LOT 3248." Consumer stated, she means she just said that, so she just diagnosed and just had a positive test this morning (at the time of reporting). So, she has taken some like over the counter like Tylenol and Mucinex. Consumer stated, those were not Pfizer drugs so, she had the container but those were not Pfizer drugs. She was looking on it. For Tylenol, there it was Lot no. BBA031. For the Mucinex, this number was long for Mucinex, NM3178901045. Consumer stated expiration dates for Tylenol was Dec2023 and Mucinex was Sep2023. The reporter was not a doctor. Consumer stated she got vaccine at the (site name withheld) site. That's first two she got at (voice not clear) office and then she got the third one at (facility name withheld). She didn't remember the dosage.  Follow-Up (06Jun2022): Follow-up attempts are completed. No further information is expected.
Mother described the patient making "jerking" motions with all of her limbs followed by tensing up of her whole  body for about 15 seconds. Afterward she soon began acting normal. About 1 hour later "her whole body stiffened up" again. Parents brough the patient to the ER. Labs were done as described below. Vital signs were WNL. Patient was observed in the ER for 2.5 hours and was acting normal for the duration of this observation period. Patient was discharged home with parents with instruction to follow up if symptoms return.
have had varying degrees of unexpected vaginal bleeding since a day or two after my second vaccine. This ranges from light spotting to a regular menstrual flow.  It has not stopped, although some days it is much less than others.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the arm left on 12May2021 at 17:00(at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and ethinylestradiol, levonorgestrel (ETHINYLESTRADIOL/LEVONORGESTREL); from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 21Apr2021 at 17:00 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 14May2021, the patient experienced varying degrees of unexpected vaginal bleeding since a day or two after her second vaccine. This ranges from light spotting to a regular menstrual flow.  It has not stopped, although some days it is much less than others. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event vaginal bleeding was unknown.   No follow-up attempts are needed. No further information is expected.
Had a similar reaction as he had to the first dose. Pruritis and severe itching on his back. On call provider contacted and order to give 50mg of Benadryl IM now and may give 50mg of oral Benadryl in 8 hours. Provider f/u today and denies SOB, cough, nausea, vomiting, flushing, or rash. No visible rash. Pt scratching at upper left arm and back. Pt received  Benadryl 50mg IM last night and the first dose of 2 Benadryl 50mg caps this morning. Will continue to monitor
Patient  developed body aches, bad headache and a rash on her legs, torso front and back. She took Benadryl and has not reported further symptoms.
Sore arm, erratic heart rate (jumps between 65 and 100, muscle aches
Information has been received from a physician concerning an adult female patient who on approximately 02Oct2003 was vaccinated with a first dose of varicella virus vaccine live. Seven days post vaccination,on approximately 09Oct2003 the pt developed a mild case of chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved.  Additional information has been requested.
had a high fever; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer or other non-health care professional (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to report adverse events of the Pfizer vaccine and told that on an unspecified date, he had a high fever. Outcome for the event unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
12/22/2020 Received vaccination at approximately 1000 in left deltiod area.  Approximately 1700 12/22/2020 developed parethesia 3rd, 4th and 5th fingers diagonally to ulnar area of left palmar surface.  12/23/2020 noted paresthesia alone vertebrea with outward extension to all areas of back.
This spontaneous report as received from a Licensed Vocational Nurse (LVN) refers to a 4 month old female patient. Patient's concurrent condition and medical history was not known. On 05-DEC-2015, the 4  month old patient was vaccinated with PNEUMOVAX 23 (lot # L027732, expiry date: 23-FEB-2017). No adverse effects were reported. No product quality complaints (PQC) was reported. Additional information has been requested.
Pain in left shoulder muscle has not subsided after 3 weeks of receiving shot. Pain killers do not help.
Severe chills, for an hour and a half starting at 10:30pm.  Headache and severe tiredness.  Injection site very minimal pain/soreness.  Stiff neck.
A consumer reported that a 3 month old male received his first dose of Prevnar on 10/18/02, about 9am. He also received Polio vaccine and DPT vaccine (manuf unk) in Sep-2002. Medical history included delivery by cesarean 1 week early. On 10/19/02 at 1:30am, he spiked a fever of 102.5 deg F. which resolved that day. On the evening of 10/19/02, he spiked a fever of 102.2 deg. F. which resolved. On 10/20/02, the child spiked another fever (temp not reported). He developed rash, "resembling roseola, petechia" on the lower legs, "clustered on the bottoms of feet looking like blood blisters." He was taken to the ER and admitted to the hospital. Results of lumbar puncture revealed clear fluid and a CSF culture revealed negative cultures at 24, 48, and 72 hours. The child was discharged on 10/25/02 and the symptoms have resolved. Follow up info received 1/27/03 from the physician provided lab results and discharge summary. A physician reported that a 3 month old male received his first dose of Prevnar on 10/18/02 about 9am. He also received Polio, and DPT in Sep 2002. Medical hisotry included delivery by caesarean 1 week early. On 10/19/02 at 1:30am, he spiked a fever of 102.7 deg F which resolved that day. The child also had a decrease in oral intake and irritability. On the evening of 10/19/02, he spiked a fever of 102.2 deg F which resolved. On 10/20/02, the child spiked another fever of 102.5 deg F. He developed a rash, "resembling roseola, petechia" in the distal lower extremities, "clustered on the bottoms of his feet looking like blood blisters." He was taken to the ER and then hospitalized. Vital signs on admission were temp 36.6 deg C, heart rate 152, respiratory rate 26, blood pressure 70/40 and weight 6.6 kilos. Physical examination revealed the child had cold, mottled skin on the extremities with decreased peripheral pulses. He was irritable with no foal signs, and his skin was mottled and hypoperfused. The subject concurrent medical condition included myalgia with increased creatine phosphokinase for several years(no more precision), depressive state with suicidal attempt and psychological disorder, oesophageal ulcer and colic polyposis. Treatment included IV fluids and cefotaxime. On 10/25/02, the child was discharged and the symptoms have resolved.