chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vial was initially stored in the refrigerator on 10-JUN-2022 at 10:38PM, administration of vaccine on 11-JUL-2022; 4 patients  received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients  received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-JUN-2022 at 10:38PM, administration of vaccine on 11-JUL-2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients  received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-JUN-2022 at 10:38PM, administration of vaccine on 11-JUL-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients  received Moderna Covid-19 vaccine 31 days after the vaccine was placed in the refrigerator) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 10-JUN-2022 at 10:38PM, administration of vaccine on 11-JUL-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The patient received vaccine past the 30 day use by date as her second booster dose. It was reported that the vial did not undergo any temperature excursions. The patient received the vaccine in left arm shoulder deltoid muscle and reports no other adverse reactions or side effects. No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-606358, US-MODERNATX, INC.-MOD-2022-606361 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-606358:Same reporter US-MODERNATX, INC.-MOD-2022-606361:Same reporter
Information has been received from a licensed practical nurse concerning a 23 year old female with no medical history and no illness at the time of being vaccinated.  On 18-SEP-2007, the patient was vaccinated with a first dose of Gardasil (lot # 654539/0742U) IM in the left deltoid.  There was no concomitant medication.  On 18-SEP-2007, 5 minutes after being vaccinated, the patient experienced dizziness and she needed to lie down.  Her blood pressure was 112/76 after 20 minutes blood pressure was 102/78, pulse 80 and her dizziness resolved.  She experienced a slight headache.  On 18-SEP-2007, the patient recovered from the dizziness and slight headache.  No additional information is expected.
Patient reported pain and numbness at injection site area and shoulder. Has issues lifting arm beyond 90 degrees
Pt recvd 1st dose of vax on 24JAN91 & for 1 wk following vax pts arm was not paralyzed, but felt heavy & seemed to take an extra effort to put through motions; pt recvd 2nd dose of vax w/o adverse rxn;
This spontaneous report as received from a registered nurse refers to a 19 years old female patient. The patient was vaccinated IM with the first dose of 0.5 GARDASIL on 24-OCT-2012 (lot # and exp date unknown). On 26-NOV-2012, the patient was vaccinated with the second dose of 0.5 ml GARDASIL (lot # H015863, expiration date 24-FEB-2020). No other co-suspects were reported. No concomitant medications were reported. After her second dose, on 26 NOV-2012, the patient came back to urgent care unit after several hours with complaints of numbness in her left arm, hand and left foot and muscle weakness. No treatment information was reported. Neurological assessment was performed on an unknown date (results not provided). The patient seem medical attention via office visit. The outcome of numbness in her left arm, hand and left foot and muscle weakness were unknown at the time of the report. The relatedness for muscle weakness and numbness in her left arm, hand and left foot was unknown for GARDASIL. No additional information was provided. Additional information has been requested.
In the past 14 days are any of the following symptoms new to you and not related to an existing health condition?: New sore throat, New loss of smell, New change or loss of taste sensation
This spontaneous report was received from an anonymous reporter (demographics unknown) concerning a female patient of unknown age. The reporter stated he/she knew someone who on an unknown date received a dose of MMR II (Lot # not reported) (dose and route not reported). Concomitant medications were not reported. On an unknown date the female patient experienced many unspecified adverse reactions. The patient's outcome was unknown. Additional information is not expected.
BACK WAS HURTING ON THE RIGHT SIDE; DEATH; CHEST PAIN; SWEATING; ARM TIGHTNESS (LEFT SIDE); HEADACHE; THROWING UP; This spontaneous report received from a consumer concerned a 53 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, expiry: Unknown, batch number: Unknown) dose was not reported, 1 total, administered at left arm on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-OCT-2021, the patient experienced headache, chest pain, arm tightness (left side), sweating, throwing up. Patients back was hurting on the right side. On 21-OCT-2021, the patient died from unknown cause. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache, chest pain, arm tightness (left side), sweating, throwing up and back was hurting on the right side was not reported. This report was serious (Death).; Sender's Comments: V0- 20211061610-covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Had Shot on Thursday. My arm is still red and sore. Hot to the touch. Worried it might be infected.
Approximately 18 hours after H1N1 vaccine, awoke with BLE weakness, aching pain, muscle tightness. No treatment. MS confirmed T7 myelopathy, neg. LP.
scabs on my forearm; itching really badly; extreme swelling; redness from the shoulder down to my fingers; hot to the touch; cellulitis; it tingled; blisters on my forearm; blotches of about 6 inches x 4 inches, purplish blotches on my forearm of 1 inch x 5 inches; lymph node about the size of a Ping-Pong formed in my armpit; pain in my left bicep; redness in my left bicep; A spontaneous report was received from a consumer concerning a 67-years-old, male patient who experienced cellulitis, lymph node about the size of a ping pong formed in my armpit, it tingled, extreme swelling, blisters on my forearm, blotches of about 6 inches in to 4 inches, purplish blotches on my forearm of 1 inch in to 5 inches, hot to the touch, scabs on my forearm, redness in my left bicep, itching really badly, pain in my left bicep and redness from the shoulder down to my fingers.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    On 25 Feb 2021, prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 batch number not provided intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Feb 2021, the patient started getting redness and pain in his left bicep. He had a lymph node about the size of a ping pong formed in his armpit. He reported that the swelling was getting worse daily.  On 06 Mar 2021, the patient had redness from the shoulder down to his fingers of his left arm. There was extreme swelling, blisters on his forearm and blotches of about six inches by four inches. The site was hot to the touch and it tingled. He went to urgent care where he was diagnosed with cellulitis (Medically significant).  On 15 Mar 2021, the patient reported his forearm started itching really badly. There were multiple cabbed over blisters to that forearm. He also reported that he had purplish blotches on his forearm of one inch by five inches.  Treatment for the event included cephalexin and allegra.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.  The outcome of the events were 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.
This spontaneous report as received from a pharmacist refers to a 67 year old male patient. On 19-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 lot # M020521, exp 17-NOV-2017 intramuscular in the right arm. Other suspect therapies included influenza virus vaccine (unspecified, manufacture unspecified). On 20-OCT-2016, 2 days after onset of therapy the patient experienced swelling from injection in right arm down to elbow and also felt feverish. There was no treatment given. The outcome of injection site swelling, peripheral swelling and pyrexia was reported as not recovered. Additional information has been requested.
Patient received vaccine on 9/22 at 10:31 am.  Per patient, started having chest pain reported as "pressure" that night, and feeling "hot all over" without taking temperature.  When asked if she had heart racing, palpating, or difficulty breathing- she felt there was some difficulty breathing when "trying to breathe deep."  Patient did not call PCP or seek medical attention.    Patient was returning to vaccine clinic on 9/23 at 0900  for family members' appointments and waited, thinking clinic could treat/advise.  Temp 39.1, HR 136, Heart rate regular.  Patient also had not eaten or drank this am and feeling unwell.  Advised patient and father to call PCP today for appointment/medical advice or go to ED for eval.  Assistant manager on floor at this time and in agreement.
Patient complained of a gumball size ring, soft-medium in texture on the left side of arm near the deltoid area. The ring is accompanied by redness and tenderness as reported by patient. Patient received three vaccines on the left arm on 04/23/2008 at approximately 11:30 a.m. The three vaccines administered on the left arm were: Hepatitis B (IM), the Td (IM), and the Varicella (SQ). The patient also received a Hepatitis A(IM) and a MMR(SQ) on the right arm. Immediately after administering the vaccines, redness was noted on both subcutaneous sites (left and right arm). There were also 1 centimeter rings near the injection sites. Patient did not complain of pain or any other symptoms with the rings. Patient was given instructions and left the clinic. On 04/24/2008 at approximately 11:55 a.m. patient called the clinic to report that she had gumball size rings on her left deltoid. The rings were associated with redness and tenderness. The patient did not complain of any other symptoms. Patient stated that she is not allergic to any medications, foods or vaccines. It is unknown as to whether or not patient is taking prescribed medications.
patient was given a non authorized covid-19 bivalent vaccine for age group 6mo-4yrs, non authorized interchangeable for age group, patient started series with Moderna Mono vaccine and was given a Pfizer 6mo-4yrs bivalent, recommends same manufacture for age group.
Information has been received from a nurse concerning a "baby" patient who on 18-AUG-2009 spit up when was vaccinated orally with a dose of ROTATEQ (lot number not reported). At the time of the report, the outcome of the patient was not reported. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax 7NOV95 & c/o of aching & nausea;lasted about 3 days;able to return to school;14NOV95 c/o aching, T98.1-pt given APAP;c/o not feeling well;delirious;taken to ER;toxicity level 20;emesis;AST 7000 & ALT 4000 were elevated;
Initial misuse report received from a health care professional on 26 September 2013. The cases were received on 21 March 2014 at GPV. A dose of FLUZONE HD was given to a person over age of 65 years (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Patient developed redness and slight swelling in the right arm (arm of PNEUMOVAX 23 injection) on 8/30/2017, which is one day after the vaccine. Today on 8/31/17 the reaction seems to be better and improving. Her left arm is ok with no signs of allergy or redness. Patient reported to MD and pharmacy. MD advised patient that it could be an allergic reaction to the PNEUMOVAX 23.
Afebrile. Pt c/o red, hived area around deltoid area 6 days after injection. Size approx. 70 mm x 50 mm. Pt c/o increased body aches x 4 days after injection. No tx given. Per health department d/t size of local reaction Vaccine Adverse Event form need to be filled out.
The vaccine was for Shingle. You do not show it on the above list. My reactions were:  chills, low grade fever, headache,  I also felt weird, unable to explain the symptoms though. that was only on the day of and the day after. I had the headache for 2 1/2 days. Took Tylenol but it didn't help. So I didn't take any more.
Information has been received from a Registered Nurse (R.N.) concerning an adolescent female patient who on 25-SEP-2007 was vaccinated in to deltoid with a dose of Gardasil.  The nurse reported that immediately post vaccination the injected arm felt numb and tingly, which traveled down the arm to the fingers.  The patient described the reaction as "almost like you could feel the medication traveling".  Patient passed out and it took her a while to regain consciousness.  She also reported that an adverse event occurred with the same lot of Gardasil about 2 weeks ago, arm pain, which was previously reported to VAERS.  The nurse did not provided the lot number.  The outcome was unknown.  No other information was available at this time.  Additional information has been requested.
This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. No concurrent conditions or medical history were provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (strength, dose, route of administration, lot # and expiry date unspecified). No concomitant medications were reported. On an unknown date, after receiving ZOSTAVAX, the patient was diagnosed with shingles. The patient sought medical attention via visiting the office on an unspecified date. The outcome of the event was reported as recovered (date unknown). The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Cough  Muscle or body aches  Headache  Sore throat  Congestion or running nose
swelling and hot to touch; allergic reaction; itching around the injection site; redness around the injection site; swelling and hot to touch; very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (swelling and hot to touch), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching around the injection site), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling and hot to touch) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Grass allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid adenoma, VITAMIN D NOS, METFORMIN HCL, CARVEDILOL, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM and ATORVASTATIN CALCIUM for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced FATIGUE (very tired). On 18-Apr-2021, the patient experienced VACCINATION SITE WARMTH (swelling and hot to touch), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching around the injection site), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (swelling and hot to touch). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (swelling and hot to touch), HYPERSENSITIVITY (allergic reaction), VACCINATION SITE PRURITUS (itching around the injection site), VACCINATION SITE ERYTHEMA (redness around the injection site), VACCINATION SITE SWELLING (swelling and hot to touch) and FATIGUE (very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient applied tekno calamine lotion on the injection site for vaccination site erythema, vaccination site pruritus, vaccination site swelling and vaccination site warmth.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Non-significant follow up; 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.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-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 FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications are provided by the reporter.   This case was linked to MOD-2021-371351 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Follow up received on 01Nov2021 contains Batch number, start date for the suspect product, patient age and event were added.
4 consecutive days of fever, extreme soreness in arm of injection site, bright red heated rash on arm of site, itchiness
The pain is now in the left side only; muscle and joint pain and a pain that started in her back and went down to both of her legs; muscle and joint pain and a pain that started in her back and went down to both of her legs; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle and joint pain and a pain that started in her back and went down to both of her legs), PAIN (The pain is now in the left side only) and ARTHRALGIA (muscle and joint pain and a pain that started in her back and went down to both of her legs) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney disorder.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (muscle and joint pain and a pain that started in her back and went down to both of her legs) and ARTHRALGIA (muscle and joint pain and a pain that started in her back and went down to both of her legs). On an unknown date, the patient experienced PAIN (The pain is now in the left side only). At the time of the report, MYALGIA (muscle and joint pain and a pain that started in her back and went down to both of her legs), PAIN (The pain is now in the left side only) and ARTHRALGIA (muscle and joint pain and a pain that started in her back and went down to both of her legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Case number PHEH2013US015821, is an initial spontaneous report received from nurse on 24 Jul 2013. This report refers to an 18 year old female patient. Her medical history and concomitant medication was not reported. Nurse reported that the patient had received MENACTRA (batch number: unknown, other manufacturer) in 2007 at age 12; MENVEO (batch number: unknown) in Aug 2012 at age 17 and again MENVEO (batch number: M11077) in Jul 2013 at age 18. No events were reported following this error. No further information was provided.
Pt vax w/ flu dev diarrhea & abd cramps two days after vax. Hosp X 4 days; dx = gastroenteritis w/ resultant hypovolemia.  Pt also dev fever.  Sxs resolved.
I received vaccine this day and put all of them in baskets and labeled and ready to give and put the wrong vaccine vial (Moderna 5-11 booster only). Patient received 0.5ml of this dose and she has been informed this was the wrong one and action has been put in to call patient to come in two months for the bivalent.
1st day: after, flu symptoms, fever, sore arm, nausea.  2nd day: same, also swelling at vaccine site, with a rash, left arm lasted through 4 days. used ice & heat, has subsided
No adverse event; First dose on 08-Jul-2022 and second dose on 16-Sep-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 08-Jul-2022 and second dose on 16-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before/ any chronic or long-standing health conditions.    On 08-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Sep-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 08-Jul-2022 and second dose on 16-Sep-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 08-Jul-2022 and second dose on 16-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 08-Jul-2022 and second dose on 16-Sep-2022).    It was unknown if patient ever been diagnosed with/ tested positive for COVID-19.  No treatment medication was provided.   This case was linked to MOD-2023-716921 (Patient Link).
PATIENT RECEIVED COVID 19 MODERNA SHOT AND WAITED 15 MINUTES AND WAS FINE. 30 MINUTES LATER
Exactly one week later I noticed a big, swollen rash on my left arm in the area I received my vaccine. Red and itchy, About the size of the palm of my hand maybe a little bigger. Went away the next day.