chrisvoncsefalvay/vaers-outcomes huggingface dataset:
uncomfortable; redness; itch was persistent; looks like a bruise; burning sensation: irritated, bigger red blotchy rim; arm was sore; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation: irritated, bigger red blotchy rim), DISCOMFORT (uncomfortable), CONTUSION (looks like a bruise), PAIN IN EXTREMITY (arm was sore) and ERYTHEMA (redness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore) and VACCINATION SITE PAIN (arm was sore). On 23-Jan-2021, the patient experienced BURNING SENSATION (burning sensation: irritated, bigger red blotchy rim). On 26-Jan-2021, the patient experienced CONTUSION (looks like a bruise). On an unknown date, the patient experienced DISCOMFORT (uncomfortable), ERYTHEMA (redness) and PRURITUS (itch was persistent). On 14-Jan-2021, PAIN IN EXTREMITY (arm was sore) and VACCINATION SITE PAIN (arm was sore) had resolved. At the time of the report, BURNING SENSATION (burning sensation: irritated, bigger red blotchy rim), DISCOMFORT (uncomfortable), CONTUSION (looks like a bruise), ERYTHEMA (redness) and PRURITUS (itch was persistent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Reporter did not allow further contact; 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.
Initially had tingling in the lips (7 minutes after injection) The next day I had a fever of 104.5 with severe body aches, chills, lack of appetite, headache, weakness, productive cough and congestion.   Have had severe body aches, chills, lack of appetite, headache, weakness, productive cough and congestion since the injection as of 4/15/2021
Mom reports when she picked child up after school child complained of feeling itchy though he had not told anyone at school (around 2:30 PM). Child taken to GM home and then had hives all over body and nose and face swelling around 3:15 PM. GM gave Benadryl (unknown dose). Mom took child to Urgent Care- child got Benadryl and cortisone shot. Child missed school Wed- Friday of that week. Went to private MD on Friday 11/2/2012 for follow up and was given a PRN Rx which mom gave child only once. Child fine now. Private MD recommended no further doses of flu vaccine.
Fertility problems; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFERTILITY MALE (non-serious), outcome "unknown", described as "Fertility problems".  Additional information: Pfizer Employee stated, "I just was at the grocery store and there was somebody talking about how they have heard of somebody getting from the COVID vaccine fertility problems, it was a lady that was talking. I do not have any questions, I was just calling in as an adverse event. The person had the COVID vaccine, Pfizer COVID Vaccine, I don't know how long it had been but then now they are having fertility problems and something she was talking about. I don't even know the person, I was just at the grocery store. I just know it was a man. Well I work for Pfizer. I have no idea who the person even was I just overheard it, she was really loud."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
severe fatigue, cough, fever increasing over 2 weeks, hypoxic at ER presentation requiring oxygen. Admitted for further care and treatment
severe vertigo started Wednesday morning and still have it and can't stand up; This is a spontaneous report from a contactable consumer (patient). A 43-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 21Mar2021 16:45 (Batch/Lot Number: ER8730) at the age of 43-years-old as single dose for covid-19 immunisation. Medical history reported as none. The patient's concomitant medications were none. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She experienced side effects 3 days after the administration of the first dose of the Pfizer's COVID-19 vaccine she experienced severe vertigo started Wednesday morning and still have it and can't stand up on 24Mar2021. Adverse event result in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe vertigo included Meclazine RX. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
4AUG91 pt devel fine rash on torso & temp of 101-102, larger blotchy lesions appeared & inc on legs; 6AUG rash became "hive like", seen by MD given DPH; 7AUG seen in immun clinic; 8AUG allerg react, 9AUG glassy eyes;
Subsequent to receiving vax, the pt developed severe swelling in the left leg that extended from the knee to the groin. Prevnar and ProHIBit were both injected into the left leg. A copy of this report has been forwarded to Aventis Pasteur, manufacturer of ProHIBit.
Immediate numbness in left hand after injection that went away after about 20 minutes Nausea persisting for 2 hours "Brain fog" persisting for 2 hours
Resident received Covid19 Bivalent booster on 9/26/22- Today (10/31/22) would be his second dose of bivalent booster.
I received my first dose of the Moderna COVID-19 vaccine on Mon, March 29.  I experienced a sore arm and slight itchiness around the injection site on Tues, March 30, which subsided by Wed, March 31.  On the evening of Mon, Apr 5, the injection site became moderately itchy. All day on Tues, Apr 6, it was extremely itchy and swollen. The injection site itself had a red, swollen circle around it, with a diameter of approximately 2 inches. I treated it with 1% Hydrocortisone cream ("Coritizone 10"), Cetirizine HCI 10 mg (Zyrtec) and ice to decrease the swelling and quell the itch. It is currently 9:35 pm on Tues Apr 6th. The swelling around the injection site remains, and there is still a thin red outline around the circle (diameter still approximately 2 inches). Within that red outline, the skin color has returned to a normal color.
This spontaneous case was initially received on 02-FEB-2016. The case report was received from a (n) Health Professional and concerns a (n) patient with unknown age and gender.  Weight: not provided, Height: not provided. For concomitant medications and therapy dates refers to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): On an unspecified date, the patient received Flu vaccine . Indication not provided. Additional Suspect drug(s): ZOSTAVAX, Indication: Not provided. Reaction(s)/Event(s) and outcome: On an unknown date, after starting/treatment with flu vaccine the patient experienced an unspecified adverse event (non serious, outcome: Unknown). Action to be take: Details manually to be entered. Event treatments: Details manually to be entered. Rechallenge/Dechallenge information: Details manually to be entered. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: n/a
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 67-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020). On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site lump to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the right deltoid. In 2018, the patient stated she had small bumps resembling little mosquito bites at the site of the injection. The pharmacist did not know when the bumps first appeared. The pharmacist's call was transferred to Medical Information for additional assistance.
Chills, fever, headache, muscle aches, joint aches, nausea, diarreha, loss of appetite
pt recv vax 17FEB97 & was irritable & cried all afternoon & noc; t101 inspite of APAP;pt vomited;pt cried & vomited several x;t101 18FEB;cried most of noc;19FEB97 t100.5;dx gastroenteritis;
Expired 2nd dose given; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 019F21A) for COVID-19 vaccination.     The patient's past medical history included Hypokalemia and Osteoarthritis. Previously administered products included for Product used for unknown indication: fluzone (Manufacturer is given as BSK. Lot number: 3P3T4 Route: Intramuscular Body site: Right arm deltoid Start date: 09-Nov-2021). Past adverse reactions to the above products included No adverse event with fluzone. Concurrent medical conditions included Allergy (Codeine allergy), Allergy (Erythromycin allergy), Allergy (Augmentin allergy), Allergy (Cephalexin allergy), Type 2 diabetes mellitus, Cirrhosis of liver, COPD, Hyperlipidemia, Depression, Anemia, Adhesive tape allergy, Chronic kidney disease, Thrombocytopenia and GERD (Gastrooesophageal reflux disease with esophagitis). Concomitant products included MIRTAZAPINE (REMERON) for Depression, OMEPRAZOLE for GERD, SIMVASTATIN for Hyperlipidemia, ALPRAZOLAM for Panic disorder, METFORMIN for Type 2 diabetes mellitus, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), FUROSEMIDE, PROPRANOLOL HCL, SPIRONOLACTONE, ONDANSETRON, LORATADINE, POTASSIUM CHLORIDE and LISINOPRIL for an unknown indication.   On 25-Oct-2021 at 4:57 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Sep-2020, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Med history: Hypertensive CKD, atherosclerosis of native artery of bilat lower extremities, Moderate episode of recurrent major depressive disorder, Panic disorder without agoraphobia, cirrhosis of liver not due to alcohol. Concomitant medications included: Gentle iron 0.4milligram for anemia. No treatment drug details was reported. The vial moved to refrigerator: 29-Nov-2021. The vaccine was kept frozen with temperature monitored and excursions. The vial was set out one hour prior given to patient. There have been no side effects noted.   This case was linked to MOD-2021-399872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: follow-up received on 01-DEC-2021 contains significant information which includes added hcp, medical history, drug information and event added.
After receiving 2nd nasal vaccine-developed rash over trunk within several hours. Mother states also noted on back of thighs next day.
Pain and swelling in hands, wrists, lower legs and feet.  Red and "tired" eyes. Evaluated by MDs on 3/29 and 3/30 who patient reports diagnosed adverse reaction to MMR.  Treated with increase in dose of diuretics, rest, and analgesics.  Missed 4 days of work and filed WC claim because MMR was required for employment (rubella titre non immune.)  Back to work full-time April 5th.  Still under treatment, but improving, expect recovery in 1-2 weeks.
It started with itching at the injection site and it was all huge red circle, hot and swollen and it was shape of an heart. I had two hives on the area. Not  really painful.  I took some Claritin and put some Hydrocortisone cream on it. It took about two days before symptoms go away with these meds. This happened with second dose too but not as bad and it came a little sooner.  Sent a picture to DR to make sure I could still get the second dose.
I HAD CONTRACTED COVID-19 MID- DECEMBER 2020. Recovered from COVID, all of it's side effects, and COVID-related pneumonia by February 2021. My 1st injection took place at about 9:20am. Approximately 10 minutes later I had the 'FEELING' of my tongue swelling (although no physical sign of swelling), and I became quite light-headed/swimmy. This lasted a couple of hours, then went away. All was well until the next morning around 9:00am. I began to have flu-like symptoms including severe body aches, headache, chest tightness. As well my complexion became gray, and eyes glassy (according to those at work). By noon time I was sent home. These symptoms persisted until the next morning. I woke up feel almost normal again.  Seems the whole course took place in about 36 hours or so.
My upper arm itched for about 3 days.  This was my 5th COVID shot - with the other 4, I had no ill effects.  With this one, my arm itched and was red and lumpy at the injection site.
Within 10 minutes of receiving vaccine pt started with itchy tongue, itchy throat, ear itching, sneezing in office and was given Benadryl, 1-2 hours later after arriving home pt started with face swelling, throat closing, voice change. Pt was taken to ER- where he was given Epinephrine, Benadryl, Pepcid, steroids and IV fluids.
Erythema and mild swelling noted to injection site and left upper arm.  States mild itching.
fever, chills, body aches, fatigue, muscle soreness, headache, enlarged/swollen lymph nodes on left side of neck
pt reports feeling "unwell" and racing heart No CP No SOB no itching or rash. BP 165/98 P-70 REgular o2 98% pt. reports didn't take BP meds this am.   feeling better during obs. D/C home advised to follow up with pcp for BP monitoring
After 15 minutes c/o left sided headache, left neck pain, tingling in feet and felt like her "throat was closing". Medicated with 60 mg Allegra as per vaccine protocol. O2 sat in 100%. Transported to ER in wheelchair in no acute distress.
Took the Moderna COVID19 vaccine had adverse reaction to it; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Took the Moderna COVID19 vaccine had adverse reaction to it) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Took the Moderna COVID19 vaccine had adverse reaction to it). At the time of the report, IMMUNISATION REACTION (Took the Moderna COVID19 vaccine had adverse reaction to it) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. Patient was asking whether it was safe for him to get the Pfizer Biontech COVID-19 vaccine as his second dose. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact
Multiple bouts of diarrhea to the point of needing to change clothes 5 times in less than a 24 hour period. Baby was also very weak, unable to hold his head supported and seemed overall exhausted and unwell. Also had a very low grade fever, and developed a small bump on his butt very close to his rectum. It appears to look most closely to a hemmroid, we are currently on doctors orders to monitor it to ensure it doesn?t progress. Baby also had very unusual colored dirreah appearing almost neon yello which is unlike any stools he has passed before, they also had an unusual and very unbearable odor. Again, poop stinks but not like this. His cheeks were also very rosy later in the day after the vaccination but it appears this has gone away the following day. Baby also woke up in the middle of the night with diarrhea which seemed to be causing him an unusual amount of pain, he also had a decreased appetite but that seems to slowly be improving.
PT STATED 30 MINUTES AFTER RECEIVING HER INJECTION THAT HER ARM WAS GETTING ITCHY. SHE WAS TOLD TO STICK AROUND LONGER SO THAT WE COULD MONITER HER SYMPTOMS. PT STAYED AROUND FOR 20 MORE MINUTES WITH MORE ITCHING OF THE ARM AND NO OTHER SYMPTOMS. INSTRUCTED HER TO TAKE BENADRYL INCASE IT WAS AN ALLERGIC REACTION. SHE WAS COMFORTABLE GOING HOME. SHE CALLED LATER TO NOTIFY ME THAT HER FACE WAS SWELLING. I INSTRUCTED HER TO SEE A DR ASAP.
SEVERE HEADACHE TO THIS DAY, DIARHHEA AND NAUSEA FOR 4 DAYS, 103+ FEVER FOR 4 DAYS, ENTIRE LEFT SIDE OF BODY FELT LIKE I WAS HIT BY A TRUCK, LEFT ARM SEVERELY SORE AND DISCOLORED, LASK OF APPETITE, SLEEPLESSNESS, WEIGHT LOSS.
Patients received Moderna COVID-19 vaccine monovalent instead of the bivalent vaccine for their booster dose.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received Moderna COVID-19 vaccine monovalent instead of the bivalent vaccine for their booster dose.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received Moderna COVID-19 vaccine monovalent instead of the bivalent vaccine for their booster dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received Moderna COVID-19 vaccine monovalent instead of the bivalent vaccine for their booster dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients received Moderna COVID-19 vaccine monovalent instead of the bivalent vaccine for their booster dose.).    No concomitant medication information was provided.  Patient received booster dose. It was reported that no adverse effects were noted.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2022: Follow up received contains non-significant information: Updated QE ID number. On 09-Nov-2022: Follow up received wherein patient's DOB and suspect drug dosage information updated.
A Moderna vaccine was given to a 17 years old today. He will be 18 in 3 months. The mistake was recognized 4 hours latera when  we were scanning his form into the system. Four hours later he is having no reactions or side effects.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Shingrix (batch number C7B9P, expiry date unknown) for prophylaxis. On 17th August 2018, the patient received the 1st dose of Shingrix. In August 2018, immediately after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, injection site warmth, fever, injection site bruising and injection site erythema. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, injection site warmth, fever, injection site bruising and injection site erythema were unknown. It was unknown if the reporter considered the injection site pain, influenza-like symptoms, injection site warmth, fever, injection site bruising and injection site erythema to be related to Shingrix. Additional details reported as follows: The patient experienced painful injection, and redness just below injection site that wrapped around the arm. The pharmacist provided lot number as captured in pharmacy database, but could not confirm if it was from antigen vial or carton. The expiration date was not available.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. Administered doses of vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 03-MAR-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot number N020352 (expiration date: 10-APR-2020) and VARIVAX, lot# N021720, expiration date: 10-AUG-2019 (exact dose, site and route of administration, frequency were not reported) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.