chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Decreased appetite, injection site in right deltoid has local swelling, redness, tenderness, soreness, and warmth.
She has not been able to get out of bed; She hasn't eaten anything; she doesn't want water or anything; she talks nonsense to me; high fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (She has not been able to get out of bed), DECREASED APPETITE (She hasn't eaten anything), THIRST DECREASED (she doesn't want water or anything), ABNORMAL BEHAVIOUR (she talks nonsense to me) and PYREXIA (high fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PYREXIA (high fever). On 09-Mar-2021, the patient experienced ASTHENIA (She has not been able to get out of bed), DECREASED APPETITE (She hasn't eaten anything), THIRST DECREASED (she doesn't want water or anything) and ABNORMAL BEHAVIOUR (she talks nonsense to me). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, ASTHENIA (She has not been able to get out of bed), DECREASED APPETITE (She hasn't eaten anything), THIRST DECREASED (she doesn't want water or anything), ABNORMAL BEHAVIOUR (she talks nonsense to me) and PYREXIA (high fever) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.
This spontaneous report was received from a Licensed Practical Nurse concerning to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of 0.5 ml of GARDASIL (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse reported that in her office had recently been administering GARDASIL "in the butt muscle". Additional information has been requested.
MAJOR PROBLEMS WITH THEIR HEALTH; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced major problems with their health. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of major problems with their health was not reported. This report was non-serious. This case, from the same reporter is linked to 20221152669, 20221152816 and 20221152749.
pt recvd 1st dose of Engerix-B & several hrs p/inject devel paresthesia in both extremities; resolved on its own;
Injection site still raised and itching in a 2 inch by 2 inch area. Symptoms started 24 hours after vaccination and have not gone away.
Severe chills, upper arms and head were hot internally, but not like a fever. More like volcanic eruptions that moved up and down arms and arched from the neck to the ears and around the top of the head. Incapable of communicating the need for help. Lasted for about 6 hours. Then fully recovered.
Patient received 2nd flu vaccine. Not realizing he had already had a flu vaccine this flu season. So far no reactions reported.
Vaccine was given at 17 years old. Came in for 2nd dose and was refused dose.
pt recvd vax 10JAN95;MD visit on 11JAN95 pt's upper arm from elbow to shoulder was swollen, red, painful & warm to touch;no fever; rx w/Keflex and DPH;MD suspect local rxn to vax;although appears like exacerbation of lupus;recovered
welts on face; really itchy spots on face and neck; ears were red, hot, and itchy; ears were red, hot, and itchy; This is a spontaneous report from a contactable consumer(patient).A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 09Feb2021 as single dose for covid-19 immunisation. Medical history was none.Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection,lot number EM9810) via unspecified route of administration on 20Jan2021 as single dose for covid-19 immunisation, anatomical location was left upper arm muscle. There were no concomitant medications.Patient was took second dose of vaccine on 09Feb2021 and on 12feb2021, night her ears were real hot, she had no other symptoms at all with the vaccine, no headache or fever, her ears were red, hot, and itchy, welts on face are still there and itchy, and her neck, and on 15feb2021, she has 2 spots on two fingers, they have itchy spots on them, little bump on each one. She wondered if this was related to it, it was 3 days after the vaccine, that it started. She was not sure this was an experienced, she was curious to know if it was a side effect. Family medical history relevant to AE was none. she has taken some Benadryl. The outcome of the event was unknown.
A few days after shot, noticed hives on right arm. Two hours later, hives spread to back, neck, and both arms. Went to a minute clinic, to get checked out. Got cream and prednisone. Also stopped taking other meds for sinus infection.  By Tuesday felt better and Wednesday all hives were gone.
The left side of my neck was very sore and hurt when I turned my head to the left.  Upon examination of the area that was involved, I found a lump that would easily move around and go under my clavicle area.
1st shot was fine...2nd shot had minor side effects... slept okay Monday night after shot and Tuesday morning felt fine.. But around 1PM while watching TV got the chills and ate some soup but did not help. So I put sweats on and took a "nap" lasting to 5PM when I woke up too warm and took off my sweats. Felt tired/weak so stayed in bead till 8:30PM. Had dull headache that evening. No fever, no breathing issues no problem with taste smell. Just weak. Slept fine Tuesday night and woke up Wednesday morning feeling 90% better. By afternoon I was 100% fine on Wednesday and continue to be fine.
Information has been received from a registered nurse concerning a 14 year old female student with no known medical history and drug allergies, who on 14-FEB-2009 at 10:00 was vaccinated with a second dose of GARDASIL (lot # 661766/0652X), intramuscularly into the right deltoid. Concomitant suspect therapy included hepatitis A vaccine (MSD) (lot # 658174/1297X), intramuscularly into the left deltoid on 14-FEB-2009. On 14-FEB-2009 at 10:00 after receiving the second dose of GARDASIL the patient became pale, and fainted for approximately 1-2 minutes. Blood pressure was 120/10. It was also reported that the patient was complaining of numbness in right arm. The patient also experienced fainting after the first dose of GARDASIL when she was 14 years old. No laboratories studies performed. No further information is available.
This spontaneous consumer report (initial receipt 06-Jan-2015) concerns a 9 year-old patient. On an unspecified date, the patient received AFLURIA injection (batch number not provided). On an unspecified date, the patient developed the flu after being injected with AFLURIA. The outcome was unknown.
Patient was to receive DTAP. The wrong vaccine was pulled for vaccination. BOOSTRIX (Tdap) was administered. The manufacturer was contacted for the correct procedure to follow to insure correct immunization. Mother of child was notified and the error explained. Patient was scheduled for a follow-up visit to receive DTaP.
Refractory immune thrombocytopenia; This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Refractory immune thrombocytopenia) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:  No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Refractory immune thrombocytopenia) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Refractory immune thrombocytopenia) outcome was unknown.      The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Patient experienced epistaxis, extensive skin rash and refractory immune thrombocytopenia after the first dose of Moderna vaccine.  Company Comment: This is a literature non-study case concerning a 65 year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI of Immune thrombocytopenia, which occurred after the first dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Patient developed epistaxis, extensive skin rash and Refractory immune thrombocytopenia. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company Comment: This is a literature non-study case concerning a 65 year-old, female patient with no reported medical history, who experienced the serious (due to medically significant) unexpected, AESI of Immune thrombocytopenia, which occurred after the first dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Patient developed epistaxis, extensive skin rash and Refractory immune thrombocytopenia. The outcome was not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report was received from a pharmacist and refers to a 50 year old male patient, with no drug reactions or allergies. Information regarding the patient's pertinent medical history, concomitant and historical drugs was not provided. On 14-AUG-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # R005345 with expiration date of 01-MAR-2020, as vaccination (anatomical location was not privided). Then, on the same day, the patient reported having "chills and fatigue". It was reported that the patient did not seek medical attention, no laboratory diagnostics or treatment were performed, no intervention to prevent serious criteria was need, no disability was presented, no hospitalization was need and no life threatening event occurred. The pharmacist reported that the patient was recovering. The pharmacist requested a lot check and stated "it was time sensitive". The causality assessment between chills and fatigue with PNEUMOVAX 23 was not reported.; Sender's Comments: US-009507513-1808USA008021: US-009507513-1808USA007518:
Within 24hr dyspnea, temps to 100, WBC 15K, myalgias, and headache. Prior to shot no symptoms. Arms without reaction locally. ER labs meningitis negative.
A report was received from a health care professional on 11/10/03 concerning a 2 year old female vaccinee who inadvertently received Fluvirin on 10/20/03. On 10/20/03, the vaccinee received a single dose of Fluvirin 0.5ml. At the time of reporting, the vaccinee did not exhibit any adverse effects. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Pediatric dose was administered to an adult patient; Adult use of child product; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 35-year-old female patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31st March 2024) for prophylaxis.   On 17th June 2022, the patient received Engerix B pediatric. On 17th June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 21-JUN-2022 Reporter's comment:  A pediatric dose was administered to an adult patient. The reporter was consented to follow up Additional Supportive Information: The adult patient was administered pediatric dose, which led to underdose and adult use of child product.
Extreme hives; measle like reactions; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03Apr2021 at 11:45 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as none and the patient had no known allergies to medications, food, or other products. Concomitant medications included cholesterol 40 milligrams (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 03Apr2021 at 11:45, the patient experienced extreme hives, measles like reactions all over body especially trunk back, under arms forearms, wrists fingers and ankles. Since the vaccination, the patient had not been tested for COVID-19. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the events. The clinical outcome of the events extreme hives and measles like reactions all over body especially trunk back, under arms forearms, wrists fingers and ankles was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was seen on 5/17/10 for his 12 mo physical. He had a mild ROME with patent PET. Afebrile, has green nasal D/c x wks. occ cough. He rec'd immzs. on 5/21/10, pt had a generalized seizure assoc. with 100.8 (R) temp in ER, after Recd with TYLENOL for a low grade tactile temp. His ER eval (CXR, CBC with (L) shift, BCX) were n. On 5/24 he had coxsackie virus was afebrile.
Information has been received from a lawyer regarding a case in litigation concerning a female of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 10-JAN-2012, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of erythema of extremities in a 60-year-old male patient who received SHINGRIX (batch number 49R72, expiry date 13th March 2021) for prophylaxis. On 20th November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities, skin warm and itchy upper limbs. On an unknown date, the outcome of the erythema of extremities, skin warm and itchy upper limbs were unknown. It was unknown if the reporter considered the erythema of extremities, skin warm and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The patient experienced redness, itching, warmth to the touch that extended from 1 inch above the site to his elbow. The reporter consented to follow up.
Pt stated that she is having numbness, and tingling down both arms started about 3-4 days later, also c/o chest discomfort, pt is afraid to get the  second shot that is in about 1 week
High pitch crying for at least 3 hours, inconsolable with decreased feeding. Event occurred about 24 hours after the Pediarix shot.
Starting at 14:30ish, approximately 3 hours after injection, I started experience body aches down my spine accompanied by a minor headache and low grade fever. As the evening progressed so did the body ache severity and grade of fever. By 19:00 I had a fever of 102.3 F, had severe body aches, chills, night sweats, and a severe headache. At this time I took 1000 mg of Acetaminophen. At approximately 23:00 I woke-up in the night drenched in sweat, had a high-grade fever of 102.7 F, severe whole body aches, dizziness, and a feeling of being disconnected from reality. I took 1000 mg more Acetaminophen and tried to go back to sleep. However, I experienced insomnia and a tingling sensation that ran from the top of my head to the small of my back every time I shifted in bed trying to get comfortable. I again took 1000 mg of Acetaminophen at 05:00 to keep the fever under control. I managed to get out of bed and tried light walking to help with circulation to offer some relief to the persistent headache that did not abate with the Acetaminophen. The body aches, fever, dizziness, chills, , and tingling sensation - from crown of head to small of back - upon moving head side to side persisted throughout the day; the severity of symptoms was abated approximately 30 min - 45 min post Acetaminophen administration. The night of the 22nd I experienced terrifyingly vivid nightmares, fever -- 101.9, body aches, and chills throughout the night; however, I did not experience any night sweats. I continued with a regiment of 500 mg of Acetaminophen every 4 hours. Saturday, 10.23.21, the symptoms finally began to subside and the Acetaminophen regimen was stopped at approximately 0900. The bulk of the symptoms had fully subsided by Monday, 10.25.21; however, occasional body chills are still experienced to current date 10.27.2021.
Seen 2 days later at clinic with severe swelling in Left arm, where IPV (aventis) and DTap (sanofi) were given.
On 12/24/00, had hives, itching on entire body, fever of 101F and swelling of arm. Took Benadryl. On 12/31/00, Hives were less, had a slight fever, swelling of arm was less that 1/2 dollar-sized. Took Benadryl.
About 15 mins after the shot, I felt a little dizzy. Within 45 minutes I felt like I had hives on left side of my body and face that spread to the rest of my body and mouth. I took an antihistamine about an hour later. I called my doctor and she told me to take a Benadryl. That calmed things down a little bit. I became very tired throughout the day. I missed the rest of work for the day. I started having a fever that night. I went to bed early got up the next morning and still had a fever. I took Benadryl, antihistamine, and aspirin. I felt like I had flu, so I stayed home and slept. I had a bad headache and a low-grade fever at about 99 degrees. I don't have a rash, but I feel like I'm going to break out in one. I went to bed early on Saturday night. I woke the next morning and felt a little better. I felt like I had another fever. I took aspirin. I had gone out then came home and felt sick again. I was tired, felt like I had flu, and I had massive body aches.  On Friday after 1st hour everything was getting inflamed. On Sunday the inflammation went down. Today I still have pretty bad body pain. My muscles are very tightened up. I still have the hive feeling. I got a fever again. I took temp and it was 99 degrees. I feel flushed and tired. The hive feeling came back mainly on left side. My arm on Friday started to swell up, bruised, sore, and puffy. Tonight, I took an aspirin and an antihistamine. My tongue feels like it is going to break out in a rash too. I didn't do anything all weekend. I had COVID back in March 2020. I have only been prescribed Benadryl.
Large red rash upper left arm. Area affected was approximate size of a pancake. Area was sensitive to the touch but mostly itchy.
headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-743693 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743693:Wife case
injection site was red; injection site was itchy; injection site was burn; injection site was swollen; A spontaneous report was received from a consumer concerning 65-year -old, male patient who was administered Moderna's COVID-19 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22-JAN-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On  22-JAN-2021 the patient experienced the events injection site was red, injection site was itchy, injection site was burn, injection site was swollen. Treatment medication included alcohol swab.  Action taken with the second dose of mRNA-1273 vaccine was not reported.  The outcome of events injection site was red, injection site was itchy, injection site was burn, injection site was swollen was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Localized swelling, heat, redness and itching from day of vaccination to 2/21/2021. At that point swelling went down and a depression and possible muscle atrophy at same site. Localized tenderness persists.
Seizure - like activity noted on 7-22-09 -> patient taken to ED.  CT done patient had received VARIVAX and HAVRIX vaccines on 7-20-09