chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient had COVID prior to vaccination. It was unknown if the patient received other vaccines in four weeks or other medications in 2 weeks. The patient experienced muscle aches and headache on 08Jan2021. It was reported that the patient was complaining of continuous muscle aches and headache four days after receiving the vaccination (as reported). The patient has not been tested for COVID post vaccination. The outcome of the events was not recovered.
It started with back pain, weakness, general malaise in the first 15 minutes. She evidenced itchiness on inside of her elbows. By direction of a nurse over the phone, I gave her Tylenol. After half an hour, by 9:45 her face and ears were flush red, and she started swelling in lips, eyes, ears, cheeks. I took her to family practitioner at 11AM and gave her prescribed Benadryl. Her symptoms progressively lessened throughout the afternoon. I gave her another dose of Benadryl before bed. She appeared normal the next day, though still had some itchiness.
This spontaneous report as received from a physician refers to a 12 years old male patient with asthma. The patient was vaccinated with lot # (H019034) ZOSTAVAX on 21-JAN-2013 (lot number H019034 with exp date 17-JAN-2014). No other co-suspects were reported. No concomitant medications were reported. On 21-JAN-2013 the patient received ZOSTAVAX instead of VARIVAX. It was unknown if the patient experienced any symptoms. No treatment information was reported. The outcome of wrong drug administration was unknown. Additional information has been requested.
Client reported adverse event to us on 03-31-10 in the pm via the State Health Center answering machine.  In follow up on 4-1-10: The Client received her GARDASIL (HPV) vaccine @ approximately 1 pm on 3-25-10.  Client states she felt "fine the rest of the day and evening." and went to spend the night at a friend's house (on 03/25/1020).  She reports waking up at 1 AM on 3-26-10 with the following symptoms: right-sided swollen lip, cheek and eye, and a swollen throat.  At approximately 4 a.m. she states she took x4 "over-the-counter" Benadryl tablets and by approximately 6 to 7 AM on 3-26-10 the swelling "started going down".  At 11 A.M. on 4-1-10 client states "I feel perfectly fine now."
Loss of appetite Fever Chills extreme weakness dizziness  severe diarrhea body aches headache.  No treatment yet. Still suffering with extreme diarrhea
Information has been received from a pharmacist referring to unspecified numbers of patients of unknown age and gender. There was no information about pertinent medical history or drug reactions/allergies reported. Since 19-MAY-2015 doses of ZOSTAVAX (lot# L006380, expiration date 26-MAY-2016, dose, route were not provided), which were exposed to temperatures outside the recommended range, have been administered to unspecified patients on unspecified dates. Information about concomitant medication was not provided. No adverse effects were reported. Additional information has been requested.
Hives, site hot to the touch, itching, face also breaking out in the same rash
Immunizations given on 10/30/15 and (L) deltoid area began with redness and swelling on 10/31 and brought to doctor on 11/1/15. It was area where KINRIX was given. Prescribed BENADRYL. Looking better on 11/2/15.
5 days after receiving KINRIX and PROQUAD he developed hives, joint pain and swelling. He was not able to walk due to pain. His condition improved with BENADRYL and steroids.
Patient had allergy symptoms and mild exacerbation of asthma 4 to 5 days prior to flu shot requiring bronchodilator to be added to his maintenance inhaled steroid. After flu shot at 9:20 AM observed until 9:45 AM. Came back to office at 10:00 AM with tight frequent cough without wheeze. Oxygen saturation initially borderline. Benedryl, Orapred, Xopenex given with increased oxygen saturation, decreased cough. Patient admited for observations.
Admitted 8/16/2021 to Hospital with breakthrough COVID . C/O cough, chest pain and loss of taste and smell x3 days.  Patient is fully vaccinated with Pfizer vaccine, 1st dose = May 14, 2nd dose = June 4.  Diagnosed with COVID 19 pneumonia, acute hypoxemic respiratory failure and sepsis.   Discharged 8/20/21
got red splots as well all over her body; More than 35 days in between Primary Series vaccines; itching all over/Adverse Reactions of continued itching; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching all over/Adverse Reactions of continued itching), ERYTHEMA (got red splots as well all over her body) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Primary Series vaccines) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 041B21A and 939904) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PRURITUS (itching all over/Adverse Reactions of continued itching). On 13-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Primary Series vaccines). On an unknown date, the patient experienced ERYTHEMA (got red splots as well all over her body). At the time of the report, PRURITUS (itching all over/Adverse Reactions of continued itching) had not resolved and ERYTHEMA (got red splots as well all over her body) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days in between Primary Series vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of GARDASIL first (dose, lot number and expiration date were not reported). On an unknown date, 6 months later, the patient was vaccinated with the second dose of GARDASIL 9 (dose, lot number and expiration date were not reported), which was the second dose for Human Papilloma Virus (HPV) series. No adverse effects were reported.
PATIENT STATES SHE HAD A SEIZURE 2 DAYS AFTER RECIEVING THE VACCINE
24 hours after receiving the second injection was lethargic to the point of not being able to engage in every day activities. Symptoms lasted about 48+ hours more. Also experienced a depressed mood. All symptoms were gone by 4/19/21.
spontaneous report was received from a consumer concerning a , White male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced first dose of the Moderna COVID-19 vaccine at 16 years of age / Product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026220A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the 16-year-old patient received the Moderna vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, first dose of the Moderna COVID-19 vaccine  / Product administered to patient of inappropriate age, was resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA-1273 (Lot number: 026220A). There were no Associated AEs with this product administered to inappropriate age,
onset of covid symptoms on 8/29/21, tested COVID + on 9/6/21, received Regeneron on 9/8/21, worsened symptoms - admitted to hospital on 9/13/21, requiring 2L nasal canula oxygen. started on steroids.
2 days after shot child had temp of 102 or more with back and stomach ache, loss of appetite, weight, soreness in the eyes, and ulcer in the mouth. Child was very fatigue with major back aches and sore throat. Upper abdomen was very painful. Hemoglobin went a 13.0 to a 8.6 count. Also child had chills and sweat. Child was given Tylenol for fever and pain. The illness course was 23 days. 11/14/07-records received-office visit 8/17/07-C/O prolonged fever since 7/26/07-back pain, abdominal pain eye pain, productive cough and runny nose. Last fever 8/16/07.Impression, viral infection unrelated to receiving the hepaitis A vaccine, she has antibody to HAV and does not need a second dose of HAV. Mild leucopenia.
fluid around my heart again; Moderate swelling all over my body; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (fluid around my heart again) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Fibromyalgia, Bipolar affective disorder and Allergy to antibiotic.   On 17-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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(s). On an unknown date, the patient experienced PERICARDIAL EFFUSION (fluid around my heart again) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (Moderate swelling all over my body). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PERICARDIAL EFFUSION (fluid around my heart again) and OEDEMA PERIPHERAL (Moderate swelling all over my body) had not resolved.            The action taken with mRNA-1273 in response to the event was not applicable.  The patient had right arm, leg back and left leg are all swollen and starting to get fluid around heart again. Treating with ibuprofen right now did the same after first vaccine. No concomitant medication information was provided.  Company Comment:  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.; 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.
Information has been received from a pharmacist referring to 3 newborns (numbered 178, 179 and 180). Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperatures dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-20105, there was a low temperature of 30.2F. On 09-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
About 10 days after my booster I started getting an itchy rash/hives. It?s been 4.5 months and I?m still having the rash. I take antihistamines and they help for about 12 hours at a time but the hives still arise. They just don?t itch while the antihistamines are working.
Seen in doctors office 01/29/2005, with scattered papules on back, feet, face and genitals with some crusting over on feet.  No fever, diagnosed with varicella.  Patient was previously immunized against Varicella on 04/01/1999.
This spontaneous report as received from a physician, via a company representative, refers to a 61 year old female patient. On JUL-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis.    Concomitant therapies included sterile diluent(STERILE DILUENT). On JUL-2017 the patient experienced rash. The outcome of rash was reported as recovered/resolved. The causality between the suspect drug and adverse event was not provided.
Began with headaches, elevated heart rate, chest pains and bounding pulse that continued weeks after second dose. Pressure in both ears then sudden hearing loss in right ear about one month after second vaccination (07/03/2021). Prescribed 60mg of Prednisone to reduce inflammation and hearing gradually returned to normal however tinnitus symptoms have gotten worse and persistent fluttering sound when lying down in the ear that's on the pillow.
Patient has a flat rash on her upper arm where she received the 2 vaccines (she received them both in one arm due to her lymph nodes removed on her left arm) she also had a sore arm and headache that started last night
Information has been received from a registered nurse concerning an approximately 72 year old female patient with no drug allergies and no medical history who in the 1980's on an unspecified date was vaccinated with a hepatitis B series (manufacturer unknown) (lot # not reported). On an unspecified date, blood work results revealed that the patient had no protective hepatitis B titers. Then on an unspecified date, the patient received a booster dose of a hepatitis B vaccine (manufacturer unknown) (lot # not reported). After the booster dose, the patient's blood work also revealed the patient had no protective hepatitis B titers. The patient had sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. Follow up information has been received from the registered nurse who reported that the patient thought she received the hepatitis B series (manufacture MSD or GSK) in later 1980s - early 1990s. The patient stated that previous blood work revealed that she had no protective hepatitis B titers since she had declined hepatitis B vaccine. Additional information is not expected.
Herpes zoster on right eye and bridge of nose.  Also has rash on back of head on left side radiating up
Slight pain in deltoid muscle when lifting left arm.; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: EN 5318, expiration date unknown), via an unspecified route of administration on the left arm at the age of 34 years old on 28Jan2021 at 10:45 at a single dose for COVID-19 immunisation in the workplace clinic. Patient has no medical history reported. The patient has no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight pain in deltoid muscle when lifting left arm on 28Jan2021. No treatment was received in response to the event. The patient assessed the event was non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.
Pt developed a thick shingles like rash on left side that went from sternum to backbone about 6 inches in width.
8 days after vaccine left upper arm became red and swollen. Hot to touch and intense itching. Red raised bumps noted in red area. Is this a delayed reaction? My arm was sore for a couple of days but went away and then day 8 post vaccine it became red and swollen. Have not see family doctor yet.
Patient reports right side CP that has point tenderness and is intermittent with no SOB or CP she reports this has happened in the past when she strained a muscle. She denies trauma and no known causes.
Woke up last night with bad chills and fever (103.1 F); also stabbing pains in upper thighs, cramping around shins and worse headache. Once up in the morning, mild nausea and lack of appetite, very tired (slept at least 4-5 more hours during the day), impaired concentration and ability to function, e.g. too tired to watch a movie or even part of one. Vision may have been off - or just too tired for sustained focus of eyes (could read some but had convergence difficulties). Fever reduced by ibuprofen but returning if more not taken.
A bit of the dose was running down his arm when the dose pulled the needle out; A bit of the dose was running down his arm when the dose pulled the needle out; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (A bit of the dose was running down his arm when the dose pulled the needle out) and DEVICE CONNECTION ISSUE (A bit of the dose was running down his arm when the dose pulled the needle out) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced UNDERDOSE (A bit of the dose was running down his arm when the dose pulled the needle out) and DEVICE CONNECTION ISSUE (A bit of the dose was running down his arm when the dose pulled the needle out). On 05-Apr-2021, UNDERDOSE (A bit of the dose was running down his arm when the dose pulled the needle out) and DEVICE CONNECTION ISSUE (A bit of the dose was running down his arm when the dose pulled the needle out) had resolved. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.
High Temperature; Myalgia; OSTEALGIA; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (High Temperature) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (High Temperature). At the time of the report, PYREXIA (High Temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
fever 102 degrees F first two days, fever 100 degrees F days 3 and 4.  Severe muscle aches and headache first 2 days, moderate muscle aches and headache days 3 and 4.
This non-serious initial spontaneous case, was received on 26-Sep-2017 from a physician, concerning a 03-year-old male child. The patient's medical history and concomitant medications were not reported. On 25-Sep-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, batch number: 179602P (as reported), expiry date: 30-Apr-2018, route of administration, anatomical location: not reported), explicitly coded as inappropriate age at vaccine administration. The outcome of the events was not reported. The reporter assessed the events as non-serious.
Initial report received from a consumer on 26 November 2007. A 22-year-old male patient with a medical history of mitral valve prolapse and an amoxicillin allergy, had received an injection of DECAVAC (route and site not reported), lot number U1950CA on 21 November 2007 and the following day, complained of fatigue. On 26 November 2007, five days post vaccination, the patient awoke with a red rash over most of his body. Both feet and hands were swollen and itchy. The patient went to the emergency room and received treatment with ATARAX and PREDNISONE (dose pack). The patient had not received any other vaccines during the four weeks prior to receipt of DECAVAC. At the time of the report, the patient had not recovered from the event. No further information was provided.
Large local skin reaction located distal to injection site, posterior upper arm extending into axilla mild erythema, + swelling and warmth.
Headache; Some soreness on injection site; Temporary rash on front shoulders; This is a spontaneous report from a contactable healthcare professional (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 01Mar2021 at 03:45 PM (15:45) (at the age of 45 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included allergies to certain foods and over the counter (OTC) medications; and antibiotics. The patient's concomitant medications included unspecified antibiotics. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. On 01Mar2021 at 07:15 PM, the patient experienced only a slight headache but very brief, some soreness on injection site for 1 day, and had temporary rash on front shoulders after shower but then it goes away. The patient was not sure if it's related. No treatment was received for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Some soreness on injection site" on 02Mar2021; and from the remaining events in Mar2021.   No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient after the manufacture date of expiration) in a 74-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient after the manufacture date of expiration). At the time of the report,  EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patient after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter. Expiration Date for the lot 070H21A was reported as 07-Apr-2022 with total of 173 doses. The date in which the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
After receiving 4 vaccines patient began to get lightheaded and faint. Patient was assisted to lie down, given cold wash cloth, crackers and juice. Patient stated she hadn't eaten breakfast.