chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Oral herpes outbreak 3 days post dose.; Slight injection site soreness; This is a spontaneous report from a contactable physician, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 06Apr2021 at 12:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. The patient had no known drug allergies. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 14Mar2021 at 13:00 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 09Apr2021, the patient experienced an oral herpes outbreak 3 days post dose with no other side effects (including fever), with the exception of slight injection site soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of oral herpes outbreak and included treatment with valacyclovir. The clinical outcome of the event oral herpes outbreak and slight injection site soreness was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
08/23/21 1:45pm Tongue & Left Arm Itching began               2:00pm Intermittent Nausea & light headache began               3:00pm Underside of Eyelids begins itching               4:00pm Tingling tongue & feeling not right gastrointestinally               6:00pm Pain at Injection site               7:00pm Sudden Tiredness               8:00pm Pain upon moving arm - applied ice               9:00pm Barely able to list arm above head, feels stiff, swollen, & very painful               9:30pm tongue itchiness increases, throat itching begins               10pm eyelid itch increases                         took Xyzal and other evening medication                         took tylenol for arm pain                        Slept horribly, turning onto left side & waking up shivering from pain in left shoulder. 08/24/21 After little sleep, awoke with intense itch (no rash) on my scalp, underside of eyelids, inside of ears, inside                 of nostrils, palms of hands, soles of feet, arm, back, legs & privates.                Intense internal itching increased as morning wore on.                I called Health Center. They told me to call my General Practitioner (GP)                I called GP who told me I could take Benadryl.                Benadryl only gave me some relief the middle 2 hours of every 6 hour dose. Nausea & headache continue. 8/25/21 Intense itch all over body continues              I continue to take Benadryl & my daily medications 8/26/21 2:30am awake from sleep scratching soles of feet and palms of hands.              3:30am rough, dry, itchy throat causing me to cough, 4:30 Temp 99.7              8:00am called GP; Drinking copious amounts of water to temper cough 8/27/21 GP called back instructing me to stop Benadryl & take a               script of Hydroxyzine 25mg 3x daily              which I took through 8/29/21. 8/28/21 Temp 99.6, diarrhea took Imodium AD 8/30/21 Took 2 doses of Hydroxyzine 8/31/21 Took 1 dose Hydroxyzine              Breasts tender for about 2 weeks after injection
Flu-like symptoms shortly after receiving vaccination, body aches, chills, fatigue About a month later developed very itchy rashes (in mirror images) on left and right shade of neck, inside of thighs, and on forearms.  They did not respond to Benadryl, antibiotics, anti-fungal but did respond to anti-viral acyclovir. Although the rashes are not longer visible after being treated with the anti-viral, I still continue to feel the itch of them in those places. Also, sharp bee sting-like nerve pains which are still continuing to happen. These happen largely on my arms and legs.
adult patient received dose from pediatric vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1416B) 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) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial). At the time of the report, INCORRECT DOSE ADMINISTERED (adult patient received dose from pediatric vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Patient received second booster dose. HCP confirmed that patient received her dose from a vial labeled for 6 months to 5 years.  Treatment information was not provided by the reporter.
Red swelling painful area 5/30/04 8 X 8 cm. Recovering 5/31/04
My husband was sick and tested positive for COVID-19 on  07/18/22. I isolated away from him, but that Wednesday on 07/20 in the afternoon, I noticed a sore throat that got worse over night. I tested positive that next morning. I was running a fever of 100.9, had a sore throat, aches, stuffy nose, and fatigue. I called my doctor who prescribed Paxlovid which I began taking that evening. I had a low grade fever until Saturday afternoon. I'm still taking the Paxlovid and am feeling better but I still have cough and fatigue.
Developed hives all over arms and legs three hours after vaccine. Itchy. No fever. No other symptoms or side effects reported.
Headache, Myalgia, NauseaVomiting, Chills Narrative:  Other Relevant History:
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Case number PHEH2014US004434, is an initial spontaneous report from a consumer received on 03 Mar 2014. This report refers to a female patient of unknown age. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX (batch number: not reported) into the nerve in the left arm on an unknown date. On 16 Nov 2012, she developed intense pain in the left arm where the vaccine was administered. The final outcome of the event was condition unchanged at the time of reporting. The physician stated that it will be 6 months to 1 year before the patient heals. The seriousness and causality of the event were not reported.
My 12 year old daughter had the first dose of Pfizer on 8/9/2021. Upon arriving home after the shot, she had severe vomiting and diarrhea. She was dazed and zoned out for 1-2 days after the vaccine.  She then received the second dose of Pfizer on 9/17/2021. Again, she arrived home not feeling well and had to lay down. She continued to feel unwell and rest laying down for approximately 2-3 days.  During this time, she was at times unresponsive  while resting and watching television.  Two weeks after getting the second dose of Pfizer, she developed severe anxiety and panic attacks. She had chest pain and was concerned that she was having a heart attack. My daughter had never had any noticeable anxiety or panic attacks prior to this time.  At this point, I took her to the doctor, who ordered a chest x-ray, EKG and blood work. All tests and labs looked normal. Another week or two went by and she continued to have episodes of anxiety and panic attacks.  In early November, she choked on a small piece of pasta, which sent her over the edge with anxiety. She started not wanting to eat much food, which sent us in and out of the doctor's office to monitor her weight. She gradually lost so much weight that she was admitted to the hospital in early December, and then another Hospital, where she spent one month recovering and being re-nourished by an nasogastric tube.  She is now in an intensive outpatient rehabilitation, as she learns how to eat solid foods again.
have to rush your kid to the ER right after; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient of unknown demographics who had to rush to the (emergency room) ER right after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dosage, route, frequency, lot number, route, administration site) as flu shot.  On an unknown onset and latency, the patient "have to rush your kid to the er right after" (emergency care) following the administration of INFLUENZA VACCINE.  It was reported that: "Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: Oh yeah its great Unless you have to rush your kid to the ER right after. No flu shots since then, no flu in over 11 years, No one needs a flu shot"  Action taken with INFLUENZA VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the event (emergency care).  At time of reporting, the outcome was Unknown for the event emergency care.
I'm not sure because I've had this problem since I was a kid after getting the Gardasil shot. My arms feel like their trying to go numb and it is a miserable pain the if i sit still it drives me crazy. so i'm up all night flapping around like an idiot or taking a scalding bath to burn my arms so I can try and sleep. I've gone to a neurologist and I look Absolutely perfect for a 30 yo.....but why this issue.i was just sent on my way with Lyrica that doesn't help... My mother suggested it was possibly due to the Gardasil shots....? idk just a heads up if threes more like me
This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On an unknown date, the patient was concomitantly vaccinated with PROQUAD (dose, route of administration, lot# and expiration date were not provided) and VARIVAX (dose, route of administration, lot# and expiration date were not provided). On an unknown date, the patient experienced sinus infection (also reported as "no adverse events reported"). Since 17-OCT-2017, the patient was treated with amoxicillin. The outcome of sinusitis was not provided. The relatedness between the sinusitis and PROQUAD and VARIVAX was not provided.
it hurts a little bit if she touches it; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen/It is a big red mark, probably the size of a lemon; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen; arm got red and it was little bump and then it spread and got itchy, and it was a little swollen; felt like she was going to come down with something, she didn't feel right; This is a spontaneous report from a contactable consumer (patient) reported that a 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at a single dose as the patient don't want to have COVID. Medical history included arrhythmia, mitral valve prolapse, acid reflux, high cholesterol, and heart murmur; all from an unknown date. Concomitant medications included verapamil, rosuvastatin, pantoprazole, estradiol (ESTRACE), and acetylsalicylic acid; all were taken from an unspecified date for an unspecified indication. The patient had the first dose of the vaccine 3 days ago (13Jan2021) and stated that her arm got red and it was little bump and then it spread and got itchy, and it was a little swollen on 14Jan2021. She also felt like she was going to come down with something, she didn't feel right. It is not swollen today (16Jan2021) but it hurts a little bit if she touches it. It is a big red mark, probably the size of a lemon. The patient took Tylenol, Zyrtec, and put ice on it all last night (15Jan2021), and it became little itchy and this morning (16Jan2021) it's little itchy, still red but the bump is gone. The patient was asked if she still experiencing the events and she stated that the bump was gone, but now it's like red and a little itchy, the red got bigger, it was also like she was coming down with something but so far today she feel okay. The patient underwent lab test with an unknown results on an unspecified date. The outcome of the event 'it hurts a little bit if she touches it' was unknown; event 'it was a little swollen' was recovered and not recovered for the rest of the events.   Information on the batch number/lot number has been requested.
Patient reports 8" X 6" hot red area with a 4" deep red mark in the middle.  Later she had Left, inner arm pain & left chest pain. Used ice & Benadryl. It is better today.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved.            After the first dose my arm was sore, as expected. It lasted 2-2.5 days.  Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-039887 (Patient Link).
Developed COVID symptoms the evening of April 5th.   Head ache, body ache, sore throat, cough, fatigue.  took a home test the morning of the 6th.   tested positive.   contacted my PCP to report and seek additional advice.   was directed to receive the anti-bodies infusion on the morning of the 7th.   felt great within 48 hours and resumed normal activities.
This spontaneous report was received from a physician referring to a 23 months old patient of unknown gender. No information about the patient's medical history, concurrent conditions and conocmitant medications was reported. On 15-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA injection, lot # N008823, expiry date 26-MAY-2018 (dose, route of administration and site of the vaccination were not specified) for prophylaxis. The administered dose of VAQTA underwent a temperature excursion. The lowest temperature was 32 Fahrenheit degrees and the higher was 54 Fhrenheit degrees for 70 hours. Data logger was not involved.  No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
Case number PHEH2015US020733, is an initial spontaneous report received from healthcare professional on 08 Oct 2015. This report refers to a 60 year old male patient. Medical history and concomitant medication was not reported. His vaccination history included post exposure treatment with first dose of RABAVERT (batch number: unknown) on 10 Sep 2015 (day 0), second dose on 13 Sep 2015 (day 3), third dose on 17 Sep 2015 (day 7). The patient was scheduled to get the fourth dose of RABAVERT on 24 Sep 2015 (day 14) but did not receive it until 26 Sep 2015. The lot numbers and expiry dates not available at time of this report. No adverse event was reported following the medication error. No further information was reported. Follow-up information received on 26 January 2016: This case was reported by a other health professional and described the occurrence of drug dose administration interval too long in a 50-year-old male patient who received RABAVERT. On 26th September 2015, the patient received the 4th dose of RABAVERT (injection) which led to a drug dose administration interval too long.
pt recv vax 6DEC95 & the next day devel a whole body rash, red swollen eyelids & lips & a frantic allergic itch;tx w/inj of Pred & a medrol dose pack;rash resolved into an eczema type scaly rash;itching cont for wk;
arm pain/ slight upper arm soreness; Disturbed sleep; Slightly flushness through my body; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Disturbed sleep), FLUSHING (Slightly flushness through my body) and PAIN IN EXTREMITY (arm pain/ slight upper arm soreness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Coronary artery anomaly, congenital (at the age of 49). Family history included Stent placement in 1972 and Cardiac disorder (Patient's father has a quadruple bypass surgery at 61 and stent placement at 82 years of age.). Concurrent medical conditions included Cardiovascular risk and Obesity (slightly over weight). Concomitant products included VITAMIN D3, ARGININE HYDROCHLORIDE (L ARGININ), NICOTINAMIDE RIBOSIDE (TRU NIAGEN), L-CITRULLINE and RESVERATROL for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain/ slight upper arm soreness). On an unknown date, the patient experienced SLEEP DISORDER (Disturbed sleep) and FLUSHING (Slightly flushness through my body). The patient was treated with IBUPROFEN at an unspecified dose and frequency; MAGNESIUM at a dose of 1600 mg; ACETYLSALICYLIC ACID (ASPRIN) at a dose of 80 milligram once a day and MELATONIN at a dose of 40 milligram per week. At the time of the report, SLEEP DISORDER (Disturbed sleep), FLUSHING (Slightly flushness through my body) and PAIN IN EXTREMITY (arm pain/ slight upper arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 120/72 (normal) Treated and 138/85 (Inconclusive) Untreated blood pressure.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-213281 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Updated patient medical history and added concomitant medication.
Initial report received from health care professional on 09 Dec 2010: This patient was vaccinated with only the MenCWY liquid conjugate component of MENVEO (batch number: not known), intramuscularly without being reconstituted with the MenA conjugate component. One patient out of 4 patients received had this drug administration error but the reporter was unable to determine which patient received partial dose of MENVEO.
After immunizations were administered patient was very upset and started to break out in hives.  We do not know if the hives were a result of the patient being upset or a reaction to the vaccine. BENADRYL 12.5 mg/5 mL Liquid Take 5 mL by mouth one time was given once the hives started.  Patient was monitored for 45 minutes after the hives started and was released because of improvement.
About 8 - 12 hours later, headache, body aches, fatigue. Body aches 12 -24 hours - CBD oil for the body aches; Headaches lasted another 3 days. I didn't know if I could take anything and didn't but on called Dr. (on Monday, 15th), said I could take Tylenol and maybe I took Ibuprofen then, too. Fatigue lasted about three days too. Shortly after that, I got cold sores in my nose. And on my lips, too. I have had them (cold sores) three or four times since I've had this 2nd dose. They keep coming back. I don't get them very often otherwise - maybe one in four years. I take Acyclovir; Roman Chamomile Oil and that helps if I get those used right away. It's a virus that just isn't going away. (Doctor visit was email for the prescription.)
Marked localized swelling of left upper arm 24 hours after flu vaccine administered. ? arthus reaction.
102.0 fever, body aches, fatigue, enlarged lymph nodes, These lasted 48 hours, though enlarged lymph nodes continues at time of report.
Adverse Event 1. Burning hand pain on right. the right hand was warm to touch relative to left 40 minutes after injection.  Treatment: Median Nerve Glides, Improved 99% in 24hrs with a frequency of once a day.   Adverse Event 2. Burning anterior thigh pain on left 13hrs after injection. Femoral Nerve Glides, 85% improved in 3 days with a frequency of 2-5 times a day.
Prolonged discomfort in left arm and knot in bicep; Joint discomfort in wrist, elbow and shoulder; Slight fatigue in hand; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8934) via an unspecified route of administration in the left arm on 07Apr2021 at 00:30 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 00:30, the patient experienced prolonged discomfort in left arm and knot in bicep, joint discomfort in wrist, elbow and shoulder and slight fatigue in hand. All lasted over 2 weeks to the current day. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the events prolonged discomfort in left arm and knot in bicep, joint discomfort in wrist, elbow and shoulder and slight fatigue in hand was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.