chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pins and needles from her feet; Pins and needles from her arms; My ear started burning inside like right ear; Almost hearing change like basically by 75% I couldn't hear much; I couldn't think straight, there was no concentration, no attention; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: ER2613) at the age of 35 as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Mar2021, outcome "unknown", described as "Pins and needles from her feet"; PARAESTHESIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "Pins and needles from her arms"; EAR DISCOMFORT (non-serious) with onset 18Mar2021, outcome "unknown", described as "My ear started burning inside like right ear"; HYPOACUSIS (non-serious) with onset 18Mar2021, outcome "unknown", described as "Almost hearing change like basically by 75% I couldn't hear much"; DISTURBANCE IN ATTENTION (non-serious) with onset 18Mar2021, outcome "unknown", described as "I couldn't think straight, there was no concentration, no attention".  Additional Information: Consumer stated, "I think I am having some side effects of the vaccine (Covid vaccine). I had the vaccine on 18Mar I think last Thursday and right after the vaccine in some minutes I was super dizzy, almost hearing change like basically by 75% I couldn't hear much and it lasted for 15-20 minutes and then I felt a bit better but then two days I couldn't think straight, there was no concentration, no attention like it was just like I was really dunk kind and then after it was like buzzing in the ear the first day and was like high pitch sound in the quiet room. Like in three days I started feeling needle and pins in my feet and leg, they are starting to move up and now and now its hands and arms and its day nine and I still have these symptoms and yesterday my ear started burning inside like right ear. I don't know how to explain it but the question is how long do these symptoms last, are they temporary, permanent or its the immune response or its there like some kind of reaction going on with my immune system that started whatever nerve reaction. What is happening and what do I do about it and same is it even a good idea to go get the second shot if I am having these reaction to the first one.   No follow-up attempts are possible. No further information is expected.
Not much side effects after receiving the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not much side effects after receiving the first dose) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Prescription medications (Unknown)) and Asthma. Concomitant products included ROSUVASTATIN, HCTZ, SPIRONOLACTONE, VITAMIN D3 and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION COMPLICATION (Not much side effects after receiving the first dose). At the time of the report, VACCINATION COMPLICATION (Not much side effects after receiving the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.   This case was linked to MOD-2022-438683, MOD-2022-438684 (Patient Link).
Hives over entire body 2 hours post-vaccine administration. BENADRYL 50mg PO administered.
Upper respiratory infection, tiredness, weakness, urinary infection , headaches, runny nose, elevated sugar (higher than regular levels)
Developed hives on day 13 after injection throughout body.  Sudden onset.   Responds to Zyrtec.    Diagnosed by Dr, an allergist and immunologist.
When I rub my fingers over it, it feels very rough; It is warm; Injection site was very red and swollen; Injection site was very red and swollen; Rash underneath the red and swollen area; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (When I rub my fingers over it, it feels very rough), INJECTION SITE WARMTH (It is warm), INJECTION SITE ERYTHEMA (Injection site was very red and swollen), INJECTION SITE SWELLING (Injection site was very red and swollen) and INJECTION SITE RASH (Rash underneath the red and swollen area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DRY SKIN (When I rub my fingers over it, it feels very rough), INJECTION SITE WARMTH (It is warm), INJECTION SITE ERYTHEMA (Injection site was very red and swollen), INJECTION SITE SWELLING (Injection site was very red and swollen) and INJECTION SITE RASH (Rash underneath the red and swollen area). At the time of the report, DRY SKIN (When I rub my fingers over it, it feels very rough), INJECTION SITE WARMTH (It is warm), INJECTION SITE ERYTHEMA (Injection site was very red and swollen), INJECTION SITE SWELLING (Injection site was very red and swollen) and INJECTION SITE RASH (Rash underneath the red and swollen area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: No new information provided. On 15-Apr-2021: No new information provided.
This spontaneous report was received from a pharmacist and refers to a 60 year old female patient. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, frequency reported as once, subcutaneously, lot # L000447, expiration date 08-MAR-2016. On an unknown date (reported as "an unspecified time after receiving the ZOSTAVAX"), the patient developed warmth and swelling at the injection site. The patient sought medical attention, on an unknown date she spoke with the pharmacist who instructed to use an ice pack as treatment. At the time of the report the patient was recovering from the events. The relatedness between the events and ZOSTAVAX was not provided. Additional information is not expected as no consent for further contact was given.
my lymph node are swollen; My arm still hurt like hell/I do have pain there all down my arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 (Lot number: FJ8762) at the age of 46 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Asthmatic" (unspecified if ongoing), notes: Verbatim: Asthmatic; "knee replacement" (unspecified if ongoing), notes: I take a Motrin or Tylenol for my knee; "Allergy" (unspecified if ongoing); "heart" (unspecified if ongoing); "knee is hurt" (unspecified if ongoing); "nerve pain" (unspecified if ongoing). Concomitant medication(s) included: ASPIRINE taken for cardiac disorder; ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity; TYLENOL taken for arthralgia; MOTRIN [IBUPROFEN] taken for arthralgia. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Dec2021, outcome "not recovered", described as "My arm still hurt like hell/I do have pain there all down my arm"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "my lymph node are swollen". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  Additional information: This report is not related to a study or programme. The patient did not receive any other vaccines prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE The patient may have received 0.5mL per dose instead of 0.25mL/ dose. The manufacture provided 0.5mL per single vial.
Hives and rashes start out as hallow or red rings and itchy on arms , legs, back and front of body, necks both left and right side of body.  then become red patches rashes.  Benadryl help a little.  I took Zyrtec the red hives goes away until after 24hrs then it come back. not sure if I should take the second doses.
No adverse event; Bivalent vaccine was given 2 days beyond BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD.) and NO ADVERSE EVENT (No adverse event) in a 67-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent vaccine was given 2 days beyond BUD.).    No concomitant drug information was provided.  No treatment medication information was provided.
Developed Bullous pemphigoid about 10 - 12 hours after 3rd shot in addition to feeling the aches and typical flu like post vaccine side effects.
Sharp deep pain in the center of chest, feeling of constriction around chest; pain and tingling in both feet
Initially injectable solution "wouldn't go in" as it was being administered, then it did and there was a lot of pain at the site. Site noted to be posterior on the left shoulder and  too high up on the arm, above the deltoid.
Tingling in limbs, numbness and tingling in lips, tongue and throat thickening, nausea, trouble speaking and swallowing.  I was given 25mgs Benadryl by mouth and taken directly to ER.  In the ER I was given another 25mg Benadryl by mouth, hooked up to BP monitor, heart monitor and pulse ox.  After seeing the doctor on duty I was given an injection of a steroid and Vistaril and 2 Pepcid by mouth.  The symptoms began to subside and I was released approximately 2hrs later with prescriptions for Prednisone, Pepcid, Epi-pen and told to take 50mg Benadryl every 6 hrs for 3 days.  I was to return immediately if symptoms reoccurred.
New Extreme Headaches, Stiff Neck, Fever 100-102, NAUSEA, EXTREME FATIGUE (Sleeping 20 hours a day), Sore Throat, Joint Pain in New Places, Swollen Lymph Nodes under Right Knee, Lower Back Pain, Extreme Itching (all over), and Raised Spreading Rash over Injection Site after 9 days.  THESE SYMPTOMS LASTED 3 WEEKS!  I AM STILL SUFFERING FROM SEVERAL SYMPTOMS: EXTREME FATIGUE, STIFF NECK, HEADACHES, ITCHING, AND SORE THROAT.  I have been advised not to get 2nd Vaccine at this time.
Patient reports sensation change to right side of face, cold tingling sensation.  Starting about 20-30 minutes after administration
Swelling of left arm with fever, erythema, neck and arm pain. Left arm with 7x10cm area of erythema and induration. Resolving by 12/04/06 treatment with Prednisone and Keflex.
not feeling so great; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "not feeling so great". The following information was reported: FEELING ABNORMAL (non-serious), outcome "recovering", described as "not feeling so great".  Additional information: Reporter was calling on behalf of her husband and herself. She said that her husband is a senior who is not good at walking around and he is homebound too. Her husband managed to get himself a shot to a supermarket where they did covid shots and she had a home visit for her shot. The second time they had shots was a home visit and that was in August. She wants to know if they can arrange another home visit for the bivalent vaccine. Also, she mentioned that when she had those two vaccines, she said it's like not feeling so great but she's fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300079136 same reporter/drug, different patient/AE;
Chills, Fever 100.5, Arm and Leg muscle pain, fatigue, Migraine, Nausea
This spontaneous report as received from an immunization coordinator refers to an unknown number of patients of unknown age and gender. The immunization coordinator mentioned COMVAX that was improperly stored might have been given to an unknown number of patients. COMVAX was exposed to temperatures of 32F (Fahrenheit) for 110 hours (temperature excursion not supported by stability data). No adverse effects reported. This is one of several reports from the same source (1402USA007570, 1404USA012061, 1404USA012062 and 1404USA012063). Additional information has been requested.
pt. c/o of left arm tingling, no SBO, BP 113/92; P=83;  O2-98%; R18
This spontaneous report was received from an office manager and refers to a 15 year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history reported. On 20-OCT-2016, the patient was vaccinated with the first improperly stored dose of VARIVAX, lot number M027885 with an expiration date on 30-JUN-2018 (dose, route and anatomical location was not reported) for prophylaxis. The vaccine was exposed to temperature of 7.7 Fahrenheit (F) during 24 hours. There was no previous temperature excursion. No adverse effects were reported. No data logger was involved. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA004460: US-009507513-1704USA004461: US-009507513-1704USA004462: US-009507513-1704USA004463: US-009507513-1704USA004464: US-009507513-1704USA004465: US-009507513-1704USA004467: US-009507513-1704USA004468: US-009507513-1704USA004469: US-009507513-1704USA004470: US-009507513-1704USA004471: US-009507513-1704USA004472: US-009507513-1704USA004473: US-009507513-1704USA004474: US-009507513-1704USA004475: US-009507513-1704USA004476: US-009507513-1704USA004477: US-009507513-1704USA004478: US-009507513-1704USA004479: US-009507513-1704USA004480: US-009507513-1704USA004481: US-009507513-1704USA004482: US-009507513-1704USA004483: US-009507513-1704USA004484: US-009507513-1704USA004485: US-009507513-1704USA004486: US-009507513-1704USA004487: US-009507513-1704USA004488: US-009507513-1704USA004489: US-009507513-1704USA004490: US-009507513-1704USA004491: US-009507513-1704USA004492: US-009507513-1704USA004493: US-009507513-1704USA004494: US-009507513-1704USA004495: US-009507513-1704USA004496: US-009507513-1704USA004497: US-009507513-1704USA004498: US-009507513-1704USA004499:  US-009507513-1704USA004500: US-009507513-1704USA004501: US-009507513-1704USA004502: US-009507513-1704USA004503: US-009507513-1704USA004504: US-009507513-1704USA004505: US-009507513-1704USA004506: US-009507513-1704USA004507: US-009507513-1704USA004508: US-009507513-1704USA004509: US-009507513-1704USA004510: US-009507513-1704USA004511: US-009507513-1704USA004512: US-009507513-1704USA004513: US-009507513-1704USA004514: US-009507513-1704USA004515: US-009507513-1704USA004516: US-009507513-1704USA004517:
Pt developed a large local reaction immediately post vax. No specifics were provided. From further correspondence recvd 2/8/01. it was reported that the pt has not recovered from this experience. Further info is requested.
Lightheaded, nauseous, dizzy and headache within the 15 minutes.  The hospital observed me for 5 hours.  They gave me steroids, famotidine, iv liquids and migraine cocktail. after 2 days my throat and neck swelled with my tongue and trouble breathing with sore throat.  3rd day swelling into my neck and trouble breathing.  This continued with breathing getting worse.  Second round of steroids was given 9 days later because difficulty breathing.  Covid test, flu test and strep culture taken all negative. Months later still having swelling in neck, glands swollen on and off and have to use continuous inhaler due to trouble breathing still, Levalbuterol, which I never had to do in the past.
Swollen lymph node under collarbone on left side; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 at 10:15 (Batch/Lot Number: EL3247) (at the age of 47-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medication included amlodipine besylate taken for an unspecified indication, start and stop date were not reported. The patient experienced swollen lymph node under collarbone on left side on 07Mar2021 (also reported appeared 4 days post vaccination) and continues through day 7. The patient did not received any treatment for the event. The patient did not have Covid prior to vaccination and had not tested for Covid post vaccination. Outcome of event was recovering.   No follow-up attempts are possible. No further information is expected.
Taken to ER on 9/7/99;s/s of SOB & rash.Mom states poss. allergic reaction;dx unsure.Pt. treated and released.Pt awoke later complaining of tighting in throat & rash on all extremities & was to return to ER ASAP.60 day follow-up states the pt has recovered.
Red blotchy hives on upper abdomen; This is a spontaneous report from a non-contactable consumer. A 29-year-old female patient received bnt162b2 (BNT162B2, Solution for injection; Batch/Lot Number: EL9269), dose 1 via an unspecified route of administration, administered in Arm Right on 14Feb2021 18:00 as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. The patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient's Concomitant medications included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported; probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; doxycycline (DOXYCYCLINE) taken for an unspecified indication, start and stop date were not reported. On 14Feb2021 20:00 patient experienced red blotchy hives on upper abdomen. No treatment was provided for the event. The outcome for the event was recovered on unknown date.  No follow-up attempts are possible. No further information is expected.
Patient developed left arm swelling from deltoid area down to elbow 2 days following vaccine. Patient also developed a temperature of 101.5 to 102.9 for 2 days following vaccines.
I had my vaccination on 09/06/2022. I started to have an itchy nose on 11/27/2022. On 11/28/2022 I started to feel run down and fatigued cough congestion wheezing tinnitus loss of taste abdominal pain and diarrhea by the afternoon. I took a COVID-19 test and it was positive. I started PAXLOVID on 11/29/2022. I am feeling ok on 12/07/2022 but feeling more fatigued with congestion and wondering if I am rebounding.
No additional adverse event; A 26 Year Old Patient was administered PROQUAD on 08/17/2022.; This spontaneous report was received from a registered nurse concerning a 26-year-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 17-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) subcutaneous injection, lot #U029322, expiration date: 19-MAR-2023, administered for prophylaxis (anatomical location, dose, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse events were reported.
Havrix Extra dose administration; administration of an extra dose of Engerix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 13-year-old male patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number ZP72X, expiry date 15-DEC-2024) for prophylaxis.   On 17-OCT-2023, the patient received the 3rd dose of Havrix and the 4th dose of Engerix B. On 17-OCT-2023, an unknown time after receiving Havrix and not applicable after receiving Engerix B, the patient experienced extra dose administered (Verbatim: Havrix Extra dose administration) and extra dose administered (Verbatim: administration of an extra dose of Engerix vaccine). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date - 31-OCT-2023 The heath care professional called to report the administration of an extra dose of both Havrix and Engerix vaccines. The patient received the third dose of Havrix and the fourth dose of Engerix-B which led to extra dose administered. The heath care professional asked for guidance on this situation.  The reporter did not consent to follow-up.
Approximately two minutes after receiving vaccination patient fainted. He came to consciousness within one minute of fainting where he was sweaty. He did not seem disoriented and stated that the injection site radiated and had pain for a moment prior to his fainting.
Vaccine 4/21.  Date of symptoms 4/26.  Initially went to an urgent care where they suspected PE and pt was started on anticoagulation without imaging being performed.  Pts symptoms worsened and pt later had CTA which showed Saddle Embolus with Right Heart Strain.  Transferred to hospital for possible tPa-catheter-directed therapy.  ECHO showed Significant RV dilation and moderate RV dysfunction.  b/l l/e venous doppler showed LLE acute DVT and RLE chronic-appearing DVT.
This spontaneous report was received from a physician. On an unknown date the 9 months and 23 days old patient of unknown gender was inadvertently vaccinated with a dose of ROTATEQ, route defaulted to oral (dose and lot number were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Seizure Like activity at approx 9pm that lasted approx 5 min, Parents Called EMS and were taken to Emergency Room. Seen back at the doctor on 3/23/2016 and admitted to hospital for IV fluids and observation.