chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 97-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's daughter. In March or April, the patient received a dose of shingrix in the left arm and experienced arm pain. The arm pain resolved after a few days. This was 3 of 3 cases reported by same reporter.
About 5 days after the series of vaccines were received, the patient had a very high fever >103F that lasted for about 24 hours.  The fever would respond to Tylenol, but would return prior to the next scheduled dose.  The patient was tired but did not sleep well during time of fever.  There were no other symptoms.
2/1/2021 2 PM headache   6 PM lightheaded dizzy nauseous headache light sensitivity itchy   8 PM nauseous itchy can?t lift my arm on my side dizzy headache exhaustion  11:45 PM nauseous dizzy full body aches arm incredibly painful shortness of breath crawling out of my skin I?m so itchy  2/2/2021 12:15 AM finished hysterically crying cannot use my left arm still crawling out of my skin  On and off sleep until 11 AM headache exhaustion cannot lift my arm   1:30pm my hand is frozen a claw position Can?t get out of bed headache sore throat  6pm move to couch with bad headache, nausea  and fatigue  2/3/2021 6am leave couch work - with bad headache, nausea  and fatigue  2/4/2021 In bed all day fatigue, headache, nausea   2/5/2021 a bit better
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 24-AUG-2015, the patient was vaccinated with ZOSTAVAX (0.65 ml, Lot#L016284, expiration date: 07-AUG-2016), which was improperly stored for 11 days (Incorrect product storage). The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female infant who on 11Jul06 was vaccinated with an oral 2ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). It was reported that within a few minutes, on 11Jul06, the pt vomited the medication. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
pt recv vax OCT95 & pt devel swelling, warmth, & a large area of redness to the inj site;no tx necessary;pt has recovered;
No adverse event; Patient received 0.25 mL dose instead of 0.5 mL dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25 mL dose instead of 0.5 mL dose).    No concomitant drug was reported. No treatment drug was reported. This case contains information for the 18th patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666277, US-MODERNATX, INC.-MOD-2022-666284, US-MODERNATX, INC.-MOD-2022-666280 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666277:Same reporter US-MODERNATX, INC.-MOD-2022-666280:Same reporter US-MODERNATX, INC.-MOD-2022-666284:Same reporter US-MODERNATX, INC.-MOD-2022-666278:Patient 18
shocky & collape; was hospitalized & recovered; 4FEB93 f/u no apnea or hypoxia while on cardiopulmonary monitor in hosp;
Wrong dose administered to child.  Patient received an adult dose of Hepatitis B instead of infant dose. Vaccine administered: Engerix B Lot# ahbvb986aa  exp: 7/13/2013
pt recv vax & pt devel whooping cough,which led to pneumonia;treated w/ a 10day course Biaxin;no further details were provided;
Bumps on legs /With the first shot, he thought the red bumps looked like a heat rash; Bumps on legs, like little red dots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 09:20 (Lot number: ER8727) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies to pencillin and sulfa based antibiotics" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement, start date: 2011 (ongoing). The following information was reported: SKIN DISORDER (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Bumps on legs /With the first shot, he thought the red bumps looked like a heat rash"; ERYTHEMA (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Bumps on legs, like little red dots". The events "bumps on legs /with the first shot, he thought the red bumps looked like a heat rash" and "bumps on legs, like little red dots" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of skin disorder, erythema.  Additional information: After the first shot on 22-MAR-2021 09:20, he had some bumps on his legs, like little red dots. He thought this was a heat rash, and did not think anything of it. With the first shot, he thought the red bumps looked like a heat rash. He never had reactions. The dermatologist said with his history she's 100% sure it's vaccine related. Emergency Room staff said it's a rash coming from the inside. They said they don't know much about rashes and that's why had to see a dermatologist. States he has pictures of his legs.  No follow-up attempts are possible. No further information is expected.
Got flu shot in left arm on 10/13/11. Next day had flu like symptoms that continued throughout the weekend. Monday morning noticed significant lump under left armpit. Went to see PA Monday afternoon. She said it was my lymph node. Put on anti-biotics and it went down, but is still present.
This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 21-SEP-2018, the patient was vaccinated with PROQUAD (recombinant human albumin)(lot # R011803 with a expiration date on 21-OCT-2019), by intramuscular route for prophylaxis, no adverse effects were reported.
Itchy Left Foot, Congestion, Swelling and Itchy Arm 8 days after shot.  I had itching and congestion during the week after the shot, but nothing like the reaction I had on the 14th of February.  Also was dizzy and felt like I was going to pass out.
WOKE UP ON sUNDAY WITH EXCRUCIATING BACK PAIN, TOOK IBUPROFEN, DIDN'T WORK, MONDAY PAIN WAS LOWER AND WAS EASIER TO CONTROL WITH IBUPROFEN. TUESDAY MOST OF PAIN HAD GONE AWAY, BUT NUMBNESS IS VERY PRONOUNCED AND HAS NOT CHANGED SINCE TUESDAY (6/1/21). NUMBNESS ON BACK SIDE OF THIGH AND RIGHT SIDE OF CALF AND RIGHT HALF OF FOOT ON RIGHT LEG
Patient was administered 0.25 ml of the bivalent booster instead of 0.5 ml; No adverse event; This spontaneous case was reported by a physician assistant and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of the bivalent booster instead of 0.5 ml).    No concomitant medications were reported.  No treatment medications were reported.
Caller states she received her vaccine today at 10am.  Now experiencing charley horses in left leg.  Instructed to increase fluids. rest and call PCP if condition worsening.
the first vaccine, the Pfizer vaccine but that was in September/Dates for COVID-19 Vaccine: (Start: 7 Dec 2021); I have experienced 98 percent of hair loss since receiving the second dose of the COVID Vaccine/ I noticed just sections of my hair falling out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administration date 07Dec2021 (Lot number: FJ8757) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Alopecia areata", start date: 2015 (not ongoing); "auto immune disease", start date: 2015 (not ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: Sep2021, when the patient was 53 years old, for Covid-19 Immunization. The following information was reported: ALOPECIA (non-serious) with onset Dec2021, outcome "unknown", described as "I have experienced 98 percent of hair loss since receiving the second dose of the COVID Vaccine/ I noticed just sections of my hair falling out"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "the first vaccine, the Pfizer vaccine but that was in September/Dates for COVID-19 Vaccine: (Start: 7 Dec 2021)". The event "i have experienced 98 percent of hair loss since receiving the second dose of the covid vaccine/ i noticed just sections of my hair falling out" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: laboratory test: (2021) unknown results. Therapeutic measures were not taken as a result of alopecia.  Additional information included: Consumer further stated, "Because I read in some studies that show that people (Further not clarified) who have had alopecia in the past after receiving the vaccine have experienced hair loss so I would have to said patient one of those people. The patient experienced auto immune disease by way of Alopecia areata but all of the hair regrew and I have not had any signs of any auto immune disease since then.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a licensed vocational nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 04-JAN-2016, the patient was vaccinated with a dose of GARDASIL lot # K010215, expiration date 05-MAY-2017 (route was not provided). On 04-JAN-2016, there was an incorrect product storage as the patient was administered a dose of improperly stored GARDASIL. No adverse effects were reported. It was unknown if the patient sought medical attention. At the time of the report, the patient status was unknown. This is one of several reports received from the same source. Additional information is not expected.
On day two after receiving the J&J vaccine, I now have laryngitis (hoarse voice). I visited my ENT doctor, who cannot give an explanation. This is day 33 of my condition. I have never had this condition before.
High fever (101.3), chills, generalized muscle pains, pain in large joints (hips, shoulders), headache, tight neck muscles, nausea, inability to sleep
felt like a node like where the earring would be; on the back of her ear like a lump; it was burning and hot; it was burning and hot; it stings; Nausea; Lightheadedness; bruise; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration, administered in Arm Right on 18Feb2021 18:00 (at the age of 54 years old) as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. Adverse event did not require a visit to Emergency Room/Physician Office. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. No relevant medical history (including any illness at time of vaccination). No relevant family medical history to adverse event. No relevant tests done. On 19Feb2021, the patient experienced felt like a node like where the earring would be, on the back of her ear like a lump, it was burning and hot, it stings, Nausea, Lightheadedness, and bruise. She thought it was from her glasses and she was putting Neosporin and Vaseline on it. She asked if it was a coincidence or was it from the vaccine? She said that it was a lot better. It was burning and it stung just on that one ear. It had gone down tremendously though. It was black and blue where her glasses touched. The heat was around the top of the ear. She clarified that it was her left ear. The swelling went down, and she did not really feel it yesterday, but she felt it today. She said that it started to bother her again after she had her haircut. She said that it was like a throbbing on her ear. She said that before she could not even keep her glasses on because it was bothering her. She said that she thought her ear was irritated from her haircut last night. She still went to work, and it was not so bad that she could not handle it. She said that she had her energy back as of yesterday. Her second dose is scheduled for the 18Mar2021. Therapeutic measures were taken as a result of felt like a node like where the earring would be, on the back of her ear like a lump, it was burning and hot. The outcome of the events felt like a node like where the earring would be, on the back of her ear like a lump, Nausea, Lightheadedness were recovered on 04Mar2021; and other events it was burning and hot, it stings, Nausea, bruise were recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
During observation felt hot and sweating No LOC vision blurred Responded to lying down and fluids discharged home with daughter
Approx 14 hours post-vaccination, patient's wife awoke to her husband struggling to breath. EMT was called, and he was transported to the hospital ED and passed away. ED physician believed death was related to CHF and not directly related to the Moderna vaccine.
Patiently given full primary dose (0.5 mL) of Moderna for patient's 12 and older instead of dose for 6 months-5 years.  No negative side effects noted. Issue identified when reconciling vaccinations at end of day.
phone call from mom 25FEB944 3PM t102-105 ax during noc-is ok during day; no other s/s; MD giving APAP, sponge bath, inc fluids PRN;
Narrative:  Patient reported having diarrhea started 2 days after getting vaccinated (first dose 2/22/2021) and lasted 3 days. Diarrhea has since resolved. Pt reported this ADR on 3/15/2021 when he returned for his second dose of covid-19 vaccine. Both vaccines were administered without complications.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant medications and concurrent conditions were not reported. On unknown dates in 2017 (reported as from 27-JUL-2017 to 13-SEP-2017), the unspecified number of improperly stored doses of PROQUAD lot # N010115 with expiration date 24-SEP-2019 (dose and route not reported) reconstituted with properly stored sterile diluent (MRK), were administered to the patients. The doses were stored in temperature -3.5 degrees Celsius for 2 hours and 15 minutes. There was a previous temperature excursion reported (-12.5 degrees Celsius for 50 minutes). Digital data logger was involved. No adverse effects have been reported. Product quality complaint was not involved. This is one of two reports received from the same reporter.
MIGRAINE; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 44 year old of unspecified sex. 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 not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced migraine. On 11-APR-2021, the subject experienced body aches. On 11-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine, chills, and body aches. This report was non-serious.
Pt has multiple satellite lesions over entire body to include face/mouth/torso/legs/groin/arms.  Afebrile.  General pruritis.  Headache.  Swollen lymph nodes.  Generally "feeling lousy".
After receiving dose, about 15 minutes after, at 1215, patient was getting ready to leave and she asked if she was red and the lead clincian stated that she was red in her chest, patient face red and flushed. Patient then was escorted to the observation area she was experiencing itching, no tingling, and she was very warm. Patient was placed on the litter, and her blood pressure obtained in her right arm, 201/ 113, HR 98 and oxygen 100% She was observed for a total of 60 minutes. Her redness resolved, and she was feeling more comfortable after the 60 minute observation.
Site: Pain at Injection Site-Severe, Additional Details: mild sore arm right after injection. on may 5th, it got worse (to level 8). then calmed down. On May 7th, it got worse again. walking caused lots of pain in shoulder. Patient has been taking ibuprofen 600mg every 6 hours since May 2nd.
Stomachache, fever, constant cough, irritability, rapid breathing, rapid heart rate.
About 20 to 30 minutes after her first dose of MODERNA COVID-19 vaccine the patient started feeling light-headed and dizzy.  She then nearly fainted.  After about 30 minutes she was feeling better but still went to the hospital for good measure
headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Neurologic disorder NOS.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. Not Provided          No concomitant medications were reported. The patient's  doctor requested that he wait until 2 weeks after second dose of vaccination to start any medication to prevent any drug interaction. No corrective treatment was reported.
Large local rxn -> swelling & induration of (L) thigh with blotchy red rash & hives; mild swelling of (L) knee.
Minor fever; Blurred vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (Blurred vision) and PYREXIA (Minor fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for an unknown indication.     Concurrent medical conditions included Macular degeneration.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VISION BLURRED (Blurred vision). On an unknown date, the patient experienced PYREXIA (Minor fever). At the time of the report, VISION BLURRED (Blurred vision) and PYREXIA (Minor fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Really sick; Feverish; Ached all over; In bed for a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bedridden in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced bedridden (Verbatim: In bed for a week), sickness (Verbatim: Really sick), fever (Verbatim: Feverish) and general body pain (Verbatim: Ached all over). The outcome of the bedridden was resolved (duration 1 week) and the outcome of the sickness, fever and general body pain were not reported.   It was unknown if the reporter considered the bedridden, sickness, fever and general body pain to be related to Shingles vaccine.     It was unknown if the company considered the bedridden, sickness, fever and general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient had a terrible reaction to the first of the two new shots. The patient in bed for a week really sick, ached all over, feverish, etc. The patient won't be having any more shots. The patient reported it to appropriate medical authorities. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.