chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bleeding and significant pain at injection site immediately after administration. Continued significant arm pain (current). Body aches began sometime in mid evening. Around midnight, began experiencing severe chills - feeling freezing in a 70 degree room under a pile of blankets - unable to remedy (current). Fever measured at 100.9 around 3am - uncovered to see if it would help (skin hot to touch but still feeling cold/chills) - measured @ 101.1 @ 345am. Began experiencing headache around 230am; slight nausea around 2am. Currently still experiencing all symptoms. This is a 6 month booster shot - first 2 doses only caused mild to nonexistent symptoms (mild site pain, arm soreness, slight malaise). Concerned about current symptoms.
Hep B (ENGERIX B) given along with PEDIARIX. Pt developed high fever, 105.7 (R) the next am. Taken to ER 3/12/13.
About 30 minutes after injection my arm began to tingle and felt warm on the inside. I figured it was normal, so i ignored it. It continued for about an hour. The following day my elbow ached and was difficult to move, but i figured that might be normal as well. The day after that, i noticed a small lump forming on the muscle of my elbow and it became a bit more painful. I figured it would go away but instead, over the next few days the mass got larger, more painful and I could no longer straighten my arm. I have no insurance and have not been working full time so also had no money, therefore i could not go to a doctor. Several days later I tried to lift a tea pitcher and it felt like something in my arm ripped. I called an urgent care and was told that due to it being vaccine related, they could not treat me. I then went to the health department and was again turned away. My last recourse was the hospital ER.  The doctor did an ultra sound and blood tests. She saw the swelling and bruising, she felt the mass under my skin, but could not explain any of them.  Since then my arm has develoiped more masses and the pain has spread to the bicep, fore arm and under arm areas.
throwing up; No appetite; he had just been miserable for about 3-4 days; he had been sick; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient's wife).  A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL9267, Expiry date: Unknown) via an unspecified route of administration, administered in right arm on 10Feb2021 (at the age of 75-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number - EL9261, Expiry date: Unknown) administered in right arm on an unspecified date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 17Feb2021 the patient experienced throwing up, no appetite and had just been miserable for about 3-4 days. On an unspecified date in 2021, he had been sick. The reporter stated that her husband had the second dose of the Pfizer Covid vaccine on Wednesday morning 10Feb2021. He was perfectly fine, had nothing, but this past week he had been sick with almost identical symptoms. He had been throwing up, has had no appetite and he had just been miserable for about 3-4 days. The patient was feeling better but threw up again after his medicine last night. The outcome of events was recovering.   Follow-up attempts completed. No further information expected.
Left thigh day after vaccination had two areas of redness which resolved over a few days. Then 9 days after vaccination (6/22/2022) right thigh (site of varicella) developed 3 nodules, worsening and red the next day, then today (6/24/2022) a 6 cm x 3 cm area of erythema, warmth, and induration surrounding the nodules, with enlarged right inguinal lymph nodes. No fluctuance, vesicles, or discharge.
pink, burned like peeled skin at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (pink, burned like peeled skin at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (pink, burned like peeled skin at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (pink, burned like peeled skin at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles vaccine and 2 days later and had the shingles and never had it before and not since.
Rheumatoid arthritis flare up; COULD NOT MOVE HANDS OR WRISTS; EFFECTED LUNGS; This is a solicited report based on the information received by Pfizer( MFR Control No. : 21K-163-3982983-00) from a contactable consumer (patient)   A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 subcutaneous on an unspecified date (Batch/Lot number was not reported), SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at  for rheumatoid arthritis. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rheumatoid arthritis flare up (rheumatoid arthritis) (medically significant) on an unspecified date with outcome of recovered could not move hands or wrists (non-serious) on an unspecified date with outcome of unknown, "effected lungs" (non-serious) on an unspecified date with outcome of unknown. The clinical course was reported as follows: consumer of a 65 year old female with events of non-serious rheumatoid arthritis flare up with covid shot, could not move  hands or wrists and effected lungs with humira (adalimumab). There was no reported medical history. In 2021, the patient experienced rheumatoid arthritis flare up with covid shot, could not move hands or wrists and "effected lungs." On an unknown date, rheumatoid arthritis flare up with covid shot resolved. COVID-19 vaccine was also considered suspect. Reporter's causality for Humira for all event was No Reasonable possibility.  Reporter's causality  for PFIZER BIONTECH COVID-19 VACCINE was not reported for all events   The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: The events rheumatoid arthritis flare up and joint range of motion decreased are attributed to the natural course of underlying disease (RA is a relapsing/remitting condition) and is considered unrelated to the suspect product. This case will be reassessed upon receipt of additional information. Event "effected lungs with humira" is considered unrelated to the suspect product and likely represents an intercurrent or underlying disease process. This case will be reassessed upon receipt of additional information.
Due date is July 7th, 2021. This is the first pregnancy. I had a high resting heart rate and elevate BP for one day. BP was 148/78  and HR was 135 on March 10th. I went to my doctor's office and she has me monitoring my BP and HR every day.
suffered a reaction; allergies; eyes got swollen even her throat which restricted her breathing; eyes got swollen even her throat which restricted her breathing; eyes got swollen even her throat which restricted her breathing; itching of the body; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-.  A female patient of unspecified age receivedBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient suffered a reaction; allergies, eyes got swollen even her throat which restricted her breathing, itching of the body with outcome of unknown.   The clinical course was reported as follows: She experienced the adverse reaction after getting like a week after getting the 1st dose on 29Apr2021 she said her eyes get swollen even her throat after getting the first dose she got a reaction a adverse reaction like her eyes got swollen even her throat which restricted her breathing and afterwards also itching of the body.  The patient stated that " I received the Pfizer vaccine on 29Apr2021 and I did not have any reaction immediately after however I suffered a reaction last night when I know it's been a little over week since I received it but due to the fact that I have never had I have never had any food for allergies I have never had any junk allergies I am concerned and wondering if my reaction that I had was due to the vaccine because I am due to get the second dose on the 28th which is next week. I am not sure if somehow it could be connected to the vaccine. I wonder it could have been late reaction to the vaccine whether or not I should go ahead and get the second dose".  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Lymph node inflammation in that arm where the patient was vaccinated; The patient had severe swelling and itching; The patient had inflammation at the site where got the vaccine; Case reference number US-BN-2022-001959 is a spontaneous case report initially received from a consumer via Agency (reference number: USBAV22-1049) on 17-Aug-2022 and concerns a 32-year-old male patient.  The patient's medical history and concomitant medication details were not reported.  On 08-Aug-2022, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown) at an unknown dose, route or site of administration, for unknown indication  On the same day, the patient developed injection site inflammation and lymph node inflammation with severe swelling and itching, it was painful to the touch and very tender. As reported, it was close to the injection site, the size of a small lime and went down in the last two days.  At the time of this report, the outcome of the events 'injection site inflammation', 'lymph node inflammation', 'localised itching' and 'swollen lymph nodes' was unknown.  The reporter did not provide a seriousness or causality assessment.  Additional information received from Bavarian Nordic on 17-Aug-2022 included the local BN case ID.; Reporter's Comments: A 32-year-old male patient developed non-serious events lymph node inflammation, itching and injection site inflammation on the same day when the first dose of Jynneos was administered. Lymph node inflammation is unlisted per the CCDS v1 and the PI, while injection site inflammation and pruritus are listed per the CCDS v1 and unlisted per the PI. Reportedly, the patient developed injection site inflammation and lymph node inflammation in the arm where he got a vaccine with severe swelling, itching and pain. The patient's concomitant medications and medical history were not reported. Considering plausible temporal relationship, events have been considered as related to Jynneos.; Sender's Comments: A 32-year-old male patient developed non-serious events lymph node inflammation, itching and injection site inflammation on the same day when the first dose of Jynneos was administered. Lymph node inflammation is unlisted per the CCDS v1 and the PI, while injection site inflammation and pruritus are listed per the CCDS v1 and unlisted per the PI. Reportedly, the patient developed injection site inflammation and lymph node inflammation in the arm where he got a vaccine with severe swelling, itching and pain. The patient's concomitant medications and medical history were not reported. Considering plausible temporal relationship, events have been considered as related to Jynneos.
Case number PHEH2014US025056, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 36 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 01 Dec 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excision.
I had confirmed covid in april 2021. After my second shot yesterday, I have slept for about 16 hours, I can't raise my arm above my head because it's so sore, I've been coughing horrendously (which I didn't have a cough when I had covid). Slight fever at 100.2 on and off. Called into work today.
Case number PHEH2014US019978 is an initial spontaneous report received from a medical assistant on 03 Oct 2014. This report refers to an 11 years old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of first dose of MENVEO (batch number: not reported) on 14 Sep 2006. He was vaccinated with a dose of MENVEO (batch number: not reported) on 18 Mar 2014. It was reported that he was accidentally administered this year a second dose of MENVEO (batch number: M14031) intramuscularly on 30 Sep 2014 without any complaints of patient harm after the inadvertent administration. No further information was provided.
pt recvd vax 12JUN95 & 9 days later pt devel chicken pox described as microvesicles on a pink base & very small lesions primarily on back; seen in ER:
About 6 hours after vaccine patient had swelling/retaining water hands/ankles. Patient took LASIX and swelling was gone Wednesday morning.
Nausea almost immediately following shot. Fatigue began approximately 4 hours following shot. Headache, fever, muscle pain, and intense joint pain approximately 14 hours later; took two OTC Aleve. Continued headache, fatigue, muscle, and joint pain with continued use of OTC Aleve. Aleve reduced fever and decreased severity of pain, though it did not relieve it fully the night and day after vaccine.
No adverse event; patient administered Moderna COVID-19 vaccine after the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient administered Moderna COVID-19 vaccine after the published expiration date) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 003A21A and 004M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient administered Moderna COVID-19 vaccine after the published expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient administered Moderna COVID-19 vaccine after the published expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient administered Moderna COVID-19 vaccine after the published expiration date).    Concomitant medication details was not reported by the reporter. Patient did not experience any adverse events. Treatment details was not reported by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-628687 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-628687:Same reporter.
Severe headache ; checked blood pressure and noted  220/113.. remained chronically high and seeked out medical care. Placed on metatoprol, 100 mg. Beginning to  drop  after 22 days.
States develop generalized rash, itchy 25 hours after receiving first dose of vaccine. Called her primary dr. 4 days after first dose of vaccine for continued rash. Was given a round of steroids and claritin by her pcp per patient.
chills; vomiting; nausea; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Arm Left at 07:30 on 24Jan2021 (Batch/Lot Number: EL9261) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 intramuscular, administered in Arm Left at 07:40 on 04Jan2021 (Batch/Lot Number: EK9230) for COVID-19 immunization and experienced pain on left arm. The patient experienced chills on 29Jan2021, vomiting on 29Jan2021, nausea on 29Jan2021. No treatment received for events. The events were assessed as non-serious by reporter. The outcome of events was recovered in 2021.   No follow-up attempts are possible. No further information is expected.
Information has been received from a RN concerning a patient was in May of 2000 was vaccinated with one dose of varicella virus vaccine live. In approximately June 2000, the patient developed chickenpox. Unspecified medical attention was sought. Additional information has been requested.
patient said that when she got the vaccine it hurt during the injection and then as she was waiting for 15 minute observation period she said the muscle in her right arm was twitching and her hands were tingling. Other than that she was feeling fine. I called her a few hours later to check in with her and she said the tingling in her fingers had stopped but that her arm still felt sore and was throbbing.
Arm pain at injection site, nausea, gas, red rash on arm separate from injection site, fatigue
Information has been received concerning a pt who was vaccinated on 09/13/99 with his first dose of varicella vaccine. On 07/03/00 the pt's mother notified the physician's office to report that her son had 18 pox.
Temperature of 100.1; cough; This is a spontaneous report from a contactable consumer. who is the patient.  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982, expiration date unknown), via an unspecified route of administration in the left arm on 16Jan2021 (at the age of 67-years-old) as a single dose for COVID-19 vaccination.  Medical history included blood pressure, restless leg syndrome, cholesterol, triglycerides, unknown rash, Vitamin B-12 deficiency and Viamin D deficiency. Concomitant medication included olmesartan medoxomil (BENICAR) for blood pressure, fenofibrate (FENOFIBRATE), doxepin (DOXEPIN), levocetirizine dihydrochloride (XYZAL), clonazepam (CLONAZEPAM), colecalciferol (VITAMIN D3) and cyanocobalamin (VITAMIN D12). It was unknown if the patient has any allergies to medications, food, or other products. It was unknown if the patient had received any other vaccines within four (4) weeks prior to the vaccine. The patient stated that she started yesterday, 19Jan2021, with a cough and today, 20Jan2021, the patient developed a temperature of 100.1.  After taking Tylenol "at 12" her temperature was 99.6. She noted that her normal temperature is 96.8. Treatment information included Tylenol. The clinical outcome of cough was not recovered and the clinical outcome of fever was unknown.
Janssen COVID-19 Vaccine EUA High fever started 9 hours after vaccination, continued until 24 hours after vaccination. Nausea and dizziness started 9 hours after vaccination, continued until 12 hours after vaccination. 5 weeks pregnant- spotting started 25 hours after vaccination. No proven correlation between potential miscarriage and Vaccine. Generalized, spotty red rash, slightly raised, no itch, on the front torso, from top of legs, groin area, up to shoulders, on front torso only (not on arms or back) 33 hrs after vaccination.
Exhaustion / Fatigue - significant exhaustion at about 5:30 PM.  It came as a wave while standing up talking to someone.  I fell back against wall.  I went home and fell asleep at about 8:30pm for 13 hours.  Felt tired the entire next day and went home and fell asleep at about 8:30 pm and slept for 14 hours.  Felt tired most of the day.  Felt exhausted and went to bed at 9:30 on Saturday night (the 3rd night) and slept for about 12 hours.  This is very unlike me because I normally stay up and watch a movie with my wife on a Saturday night.  This pattern of feeling exhausted by 6:00pm continues and we are now at about 3 weeks after the vaccine.  It?s improving a bit but it?s still outside the normal pattern for me.  I?m still feeling quite tired early in the evening and going to be much earlier than Normal.    Additionally, I feel like I?m not myself.  At times, my brain feels a bit foggy in that I?m not as aware or clear in my thinking as I normally would be.
This is a spontaneous report from a non-contactable consumer reported for himself, via a Pfizer sales representative. A 67-year-old male patient received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and the patient's concomitant medications were not reported.  He complained of continued arm pain beyond just the injection site. He stated that he had a steroid injection in the same arm a few weeks prior. No follow-up attempts are possible. No further information is expected.
1 day p/vax pt devel redness, tenderness & warmth @ inj site;seen by MD who dx cellulitis;pt tx w/duricef & motrin;2 days p/vax pt cont to exp inj sit tenderness & puffiness;
Patient developed cellulitis, erythema, induration, tenderness and heat in a 3 x 5 cm area around injection site on left thigh.
Swelling under my armpit.....black and blue....tender to touch...noticeably different than my right armpit in terms of swelling
Pt recvd 1st dose of Hep B vax on 26FEB92 w/o any complications;
severe sciatica-like pain in buttocks, hamstrings and lower back (initially right buttock) when lying down, walking relieved pain to some extent, improved substantially after 36 hours
I was diag7with CHF 11 months after getting the shot, was healthy up to the point when I was hospitalized