chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site itched after every shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itched after every shot) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE BESYLATE for Blood pressure high, FAMOTIDINE for Hyperacidity, TIMOLOL MALEATE (TIMOPTIC), BIMATOPROST (LUMIGAN) and PRAVASTATIN for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PRURITUS (injection site itched after every shot). In 2021, VACCINATION SITE PRURITUS (injection site itched after every shot) had resolved.            No treatment information was provided. It was Reported, Every time, around the day of the injection or the next day patient´s injection site itched. It was not red nor had a rash.This lasted between 10 days and 2 weeks each time.   This case was linked to MOD-2022-454465, MOD-2022-454495 (Patient Link).
Initial misuse report received from a health care professional on 23 September 2013. A male patient believes that he received two doses of FLUCONE High Dose within the last few weeks of reporting. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Sore injection site for 2 days, 7/8 days after injection developed a large red splotch on left arm near injection site - is very red, hard and warm to the touch, some soreness and itching.
generalized itchiness; woke up with headache; feeling fatigued; anaphylactic reaction; right arm started going numb; right arm was tingling; A spontaneous report was received from a 26-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, right arm numbness and tingling, headache, fatigue, and generalized itchiness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: OU520A/011520A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 23 Dec 2020, within minutes of receiving the vaccine, the patient experienced an anaphylactic reaction and was rushed to the emergency room (ER). When transported to the ER she began to experience throat swelling, redness of arms and chest, trouble breathing with lower chest pain shooting into lungs, and numbness with tingling in her right arm. Treatment for the event included epinephrine, steroids, and diphenhydramine.  She was released from the ER on 23 Dec 2020.  On 24 Dec 2020 patient awoke with a headache, fatigue, and generalized itchiness. Treatment for the event included ibuprofen and diphenhydramine.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, anaphylactic reaction, right arm numbness and tingling, were reported as resolved on 23 December 2020. The events of headache, fatigue, and generalized itchiness were considered resolving.; Reporter's Comments: This case concerns a 26-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot OU520A/011520A), and who experienced the unlisted events of anaphylactic reaction, right arm numbness and tingling, and generalized itchiness, and the listed events of headache and fatigue.  The events were considered to be possibly related to the vaccine due to the temporal relationship with onset on the day of vaccination.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 3-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
2-18-21 Exhaustion - chills - suction type spasm in  arms and legs actually see fluid movement- left with bumps and move -less severe  suction - stomach ache - gas - 3-15 same as above - low temp 97.2  *pain at injection site & shoulder to continued exhaustion - weakness -  spasms in fingers tightening in abdomen - nausea -  all Dr visits - no change in vitals
Info has been received from a physician concerning an overweight female pt with hypertension who was vaccinated with Hep-B. The pt had recently returned from a European business trip. The reporter stated that 48 hours after administration of the Hep-B vaccine, the pt developed bloody stools and was treated with unknown antibiotics. The pt was later dx'd with ischemic colitis. Additional info has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling bad), HEADACHE (Headache) and MALAISE (Malaise) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced FEELING ABNORMAL (feeling bad), HEADACHE (Headache) and MALAISE (Malaise). On 24-Jan-2021, FEELING ABNORMAL (feeling bad), HEADACHE (Headache) and MALAISE (Malaise) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Patient reports of left arm soreness/pain after receiving 1st Gardasil injection with a bump down her arm. No redness or bruising. Arm swollen initially. Still complains of tenderness to the touch and pain in the arm. With certain arm movements such as lifting, pain increases from a 1 to a 7 on a pain scale. Warm compresses and over the counter pain relief has not helped with pain.
Tachycardia HR 190?s, chest pain, feeling of impending doom,  shortness of breath that continues to this day, confused, unable to find words.
I had body aches, cough, and slight fever of 100. I tested positive for COVID-19. I spoke to my doctor and we decided not to take PAXLOVID because my symptoms were clearing up on their own.
Within 5 minutes of vaccine-Metallic taste, Tingling tongue, burning throat, coughing, lump in throat when swallowing, hot flushed feeling. Elevated blood pressure, elevated blood sugar.  1 hr after vaccine itchiness all over and itch welt on forehead
This is a dangerous shot. My son woke up early in the morning in terrible pain and in a cold sweat. This has NEVER happened before! Then he fainted. The next day he was still sick, fainted again and hit his head, needed stitches next to his eye and had a mild concussion from it. He could have been blinded in that eye. This website was a goose chase to get to! There are probably tons of parents who can?t report the adverse reactions their kids are suffering because of how complicated it is to even figure out where to report it. You should be ashamed of this process which lends itself to the under reporting of adverse reactions to COVID-19 vaccinations!
Mild arm pain at injection site.  I also gave been having difficulty the past 2 weeks trying to recall certain words or remember people's names. It's been enough that I noticed and it is out of character for me. It just feels off. It's not normal and I don't have memory recall issues. I hope it goes away.
Tingling in upper lip, nose, hairline and right arm. Evaluated by medics-cleared
Irregular heartbeats and heart palpitations started around early May and have continued randomly. There are times I wake up in the middle of the night with a fast heartbeat or feeling like my heart skipped a beat.
swelling & pain in area where vax given w/in 6-8hrs;APAP for pain & warm compresses for swelling;sxs disappeared w/in a day or two
body rash; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6198, Expiration date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 66-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma and acid reflux both from an unknown date. Concomitant medications included simvastatin; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), and benzonatate all taken for an unspecified indication and potassium bicarbonate , sodium alginate (GAVISCON ADVANCED) taken for acid reflux; start and stop date were not reported. On an unspecified date in Mar2021 about 8 o'clock, the patient had a body rash, no other reactions, and felt fine. She went to bed and the body rash was gone. She just wanted to make sure she can go ahead and get her second dose scheduled on 25Mar2021. No treatment was received for the event. The outcome of the event was recovered on an unspecified date in Mar2021.   No follow-up attempts are possible. No further information expected.
Feeling abnormal; WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN.  Based on the current case data, this case has been classified as invalid. This     The subject received mRNA-1273 (Moderna COVID-19 Vaccine). The report describes a case of FEELING ABNORMAL (Feeling abnormal).     No Medical History information was reported.  On an unknown date, the patient experienced FEELING ABNORMAL (Feeling abnormal). At the time of the report, FEELING ABNORMAL (Feeling abnormal) outcome was unknown. Not Provided      This case was linked to MOD-2021-168356 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No specific follow-up information recorded.
p/vax pt Dx w/ITP & treated at medical center                                                                                                                              CBC 12-2-99 normal range plt ct
One month after the second vaccine, patient suffered a sudden heart attack. Patient has no heart condition or any remarkable health issues at all.
MD reported patient experienced a migrating arthritis, muscle spasms of the forearm and an inability to grasp anything.  Resolved in 1 day.  Started hours after flu shot.
evening of 17AGU92 11-12 hrs p/recvd vax tingling feeling all over body on & off for 2 days, nausea, no vomiting, diarrhea, flushed "radiating heat";
pt recv vax 29AUG96 & 11SEP96 pt exp inflammation in rt leg & 6 inches between pelvis & knee on dorsal side, & sl transient pain;3wk later pt recovered from sl transient pain;also reported that cat bit never became infected;
RIGHT ARM WAS TENDER, ITCHY, BURNING SENSATION, REDNESS, SWELLING THROUGHOUT UPPER ARM. WORSENED AS DAY PROGRESSED. DID NOT SLOWLY IMPROVE UNTIL 8/21/16. HYDROCORTISONE CREAM 1%, COLD WATER, ICE WAS USED TO ALLEVIATE THE PAIN AND REACTION ABOUT 3-4 TIMES DAILY. AT TIME OF REPORTING (8/23/16), HAS NOT COMPLETELY RESOLVED.
pt recvd vax; T 106 R in eve p/ vax;to er;was given acetaminophen; no T day p/ inject;not reported to hlth dept until appt on 30mar95;
Intermittent tinnitus in both ears a couple weeks after the second vaccine, continuous tinnitus the last two weeks.
Several hours after shot developed pain in both ankles, swelling in both legs and feet and itching all over.  Reported above to OBI nurse on 6/8/2011 at 11:30 AM. No rash on body but still itching all over.  12:30PM developed difficulty breathing.  Taken to Medical Center by car.  Physician is treating subject for possible pulmonary embolus.  Lungs were clear per ER physician.  3:30 PM Subject still itching all over.  ER Physican unsure if symptoms from vaccination.
Dry heaves, nausea, headaches, back pain.  Started with dry heaves & headache on the 6th of March.  Continued with both and added intermittent nausea.  Began to have back pain during the 1st week.  Unable to eat more than 1-2 bites with nausea.  Took OTC pain medications.  Tele-health call to PCP on 3/16/21 and obtained prescription for Zofran, which  help a little.  Eventually, symptoms started to subside the week of 3/24/21.
pt recvd 3 doses of Engerix-B & titer test indicated did not respond;
Whole upper arm moderate swelling and redness with heat. Redness opposite side of injection site (lymph nodes).
Erythematous papular rash (L) upper thigh improving w/ cool compresses. No systemic illness or involvement.
2 hours post vax, the pt experienced swelling at site with redness. By bedtime swelling increased as well as extension of redness and site on left deltoid became very tender. Also, she describes feeling listless. Unable to lay on left side during the night due to pain.
CHILLS; MORE SEVERE HEADACHE; 104 PLUS FEVER; NAUSEA; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in MAR-2021 for prophylactic vaccination. The patient experienced terrible reactions which include 104 plus fever, chills, nausea and terrible headache (Dose number in series 1). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104 plus.  The patient recovered from 104 plus fever after four days, and outcome of chills, nausea and terrible headache was not reported. The patient received booster covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 14-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JAN-2022, the patient experienced same side effects as of initial vaccination which included chills, 104 plus fever, nausea but more severe headache (Dose number in series 2). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104 plus. Patient was wondering if that was an allergic reaction. Patient was looking for better understanding why his side effects were so severe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the more severe headache, 104 plus fever, chills and nausea was not reported. This report was non-serious. This case, involving the same patient is linked to 20220130689.
Patient started to experience symptoms within 1-2 days of receiving the second covid shot.  She started with shortness of breath.  She went to the ER on Sat Oct 9th due to shortness of breath.  She saw her regular MD during the week who ordered bloodwork.  The blood work showed elevated d-dimer levels and she was sent to the ER again on today 10/15.  She continues to have SOB, back pain, chest pain, chest tightness, HR palpitations and tachycardia.  She is being evaluated for possible lung clot
red, warm right away that day.  2 days later, injection site cleared up, but the red, warm area had migrated down her arm, slight raised area of definite demarcation.  Pt had relief with ice, only iced once, advised to ice a couple times per day and be seen immediately if worse.  No s/sx of anaphylaxis, no other worries.
(L) arm reaction redness, swelling, warmth PNEUMOVAX arm that had reaction. Localized reaction approx. 4 inches across & approx. 1 in wide. Pt continues to have soreness. Is using ice at 10-15 intervals will let us know if not improving by end business 6/24/11.
Attendee received second dose Pfizer vaccine at 09:40 am in the right arm.  Lot# FE3590. Attendee was directed to observation area.   At 09:50 pm the attendee fainted and was caught by the RN, who prevented him from falling to the floor. Attendee's skin was cool and clammy. Attendee immediately became alert Attendee's respirations were not tachypneic or dyspneic. Attendee assisted to the cot to lie down, legs elevated.   HR:  45   BP:  126/65   RR:   16   O2Sat%:  96      09:56 - Attendee stated he felt better, no longer diaphoretic, or pale.  Drinking water.  HR:  59   BP:  124/68   RR:   18   O2Sat%:  100  10:04 -No voiced complaints- skin warm and dry.   HR:  94   BP:  112/68   RR:   18   O2Sat%:  98  10:09 -No voiced complaints- skin warm and dry.   HR:  82   BP:  112/58   RR:   18   O2Sat%:  98  10:20 -No voiced complaints- skin warm and dry.  Had finished a 16.9 fluid ounce water. HR:  88   BP:  118/64   RR:   18   O2Sat%:  98  10:25 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with his mother.   Attendee did not have any reported escalation of symptoms and was able to walk out of clinic independently.  Attendee was retained for a longer observation time to make sure that it was safe for them to leave.
Pt devel a rash, itching, & loss of energy w/in 12 days of flu vax;  rash began @ the inject site approx 1 wk p/vax; 9OCT91 pt was seen @ MD office w/a generalized rash & t101.6; Seen in ER t103 admitted; dx hypersensitivity rxn;
Information has been received from a nurse referring to a teenager female patient. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patient was vaccinated with three series of RECOMBIVAX HB (lot#, dose, route and vaccination site unknown) for vaccination as a child (inappropriate schedule of drug administration). The patient recently (date unspecified) had titers drawn for Hepatitis B, and the results were negative. As treatment, the patient would begin a new three dose series of RECOMBIVAX HB beginning on 29-JAN-2016 (today) (Extra dose administered). The outcome of the events was unknown. Additional information has been requested.
shaking; nausea; burning; itching; rash; This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included valaciclovir hydrochloride (Valacyclovir) tablet for burning sensation and pruritus and cortisone cream for burning sensation and pruritus.   On 2nd August 2021, the patient received the 1st dose of Shingrix. In October 2021, the patient started Valacyclovir at an unknown dose and frequency. In August 2021, the patient started cortisone cream at an unknown dose and frequency. On 15th August 2021, 13 days after receiving Shingrix and 7 days after starting Valacyclovir, the patient experienced rash. On 29th August 2021, the patient experienced burning sensation and pruritus. On 26th October 2021, the patient experienced tremor and nausea. The action taken with Valacyclovir was unknown. The action taken with cortisone cream was unknown. On an unknown date, the outcome of the burning sensation, pruritus, rash, tremor and nausea were not recovered/not resolved.   It was unknown if the reporter considered the burning sensation, pruritus, rash, tremor and nausea to be related to Shingrix. It was unknown if the reporter considered the rash, tremor and nausea to be related to Valacyclovir.  Additional details were provided as follows: The case was reported by patient. The patient was currently experiencing a rash, burning, itching, nausea, and shaking after receiving his first dose of SHINGRIX. The patient initially developed a rash and 2 weeks later, he experienced burning and itching. The patient went to a local pharmacy where he was recommended a cortisone steroid cream. The symptoms got worse. The patient went to his doctor who prescribed him  valacyclovir. On the day of reporting the patient was on 7th day of taking valacyclovir.  The patient saw that the rash had spread to 5 new areas and started feeling nausea and noticed his body shaking. The reporter did not consent to follow-up. The reporter did not provide any additional information. There was discrepancy in the onset date of rash, it was captured as 15 August 2021 as per structured field.
On October 24, I had a cystoscopy. They destroyed the kidney stone and added a stint. On my way home, I was in so much pain, I stopped at another emergency room. I feel like I contracted COVID-19 there. On November 7, 2022, they removed the stint and told me I had a bacterial infection. The next week, I started feeling sick. I took two COVID-19 tests at home. The results were positive for both tests. I had a mild fever that fluctuated between 99-degrees to 101-degrees. My wife took my blood pressure. It was low. She took me back to the emergency room on Friday, November 11, 2022. They tested me for COVID-19. The results were positive. I also had a bacterial infection and was septic. They transferred me to a different hospital on November 12, 2022. I was there until November 15, 2022. When I was released, I was negative for COVID-19 and everything else. It took me about three weeks to start feeling better, but it could have been a combination of things.