chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; muscle soreness; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and MYALGIA (muscle soreness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chest pain. Concurrent medical conditions included Drug allergy (prevacid), SLE nephritis (glomerular disease in SLE) since 25-Jun-2021, Tension headache (tension type headache) since 28-Feb-2021, Hypertension (constant for a while) since 2007, SLE syndrome aggravated (possible SLE flare up at time, no blood work taken.) and Depression. Concomitant products included FLUOXETINE for Depression, TRAZODONE for Tension headache, HYDROXYCHLOROQUINE, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), PREDNISONE, SPIRONOLACTONE, ARIPIPRAZOLE (ABILIFY), VITAMIN D NOS and FOLIC ACID for an unknown indication.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (muscle soreness). At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (muscle soreness) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Treatment history was not reported. Patient had not taken any OTC medicines to try to alleviate symptoms since receiving moderna dose.      This case was linked to MOD-2021-291097, MOD-2021-293779 (Patient Link).
This is a spontaneous report from a contactable consumer received via a sales representative. A female patient in her 6th decade received PREVNAR 13 via an unspecified route of administration, on an unspecified date in 2015, about a year before the report, at 0.5 ml single. Medical history included ongoing lung disorder. Concomitant medications were not reported. The patient developed Kawasaki syndrome on an unspecified date in 2015, one or two months after vaccination. The event resolved on an unspecified date in 2015.
patient showed me her arm today 04/14/2019. patient says she has been putting alcohol on the spots but nothing on the knots.
I received booster shot on Friday, January 14th (my first 2 were Moderna. 2nd dose 2-10-21) and my arm pain that started at the injection sight has spread.  It now stretches from my wrist in one painful line up to my armpit and down along my ribs. The most painful parts are the inside bend at my elbow, the armpit and each rib sensitive to touch.
Patient complained of mild dizziness and a hard lump/swelling developing at the site of vaccine (right deltoid) about 10 minutes after receiving the vaccine. Pt assessed and VS found to be within normal limit.  Dizziness subsided within a few minutes and patient stated feeling stable to be discharged home approximately 35 minutes after vaccine administration. This RN went over side effects x allergic reaction with patient
"Covid arm". Red rash at injection site appeared 10 days after jab. Hot and tender, warm to touch. Slightly itchy.
difficulty deep breathin - very irritated eyes, thick greyish secretion both eyes - chills
Pt received vaccines on 2/2/06, later in the day his right leg became swollen and painful, refused to walk or move the leg.  Child taken to emergency room, given tylenol with codeine.  Returned to our office 2/3/06, fever of 104.0 axillary reported by mother of child earlier in the morning , swelling and pain is decreasing.  CBC within normal limits.
Fever, pain, severe swelling, hives. Told to ice and take motrin. Still discolored, swollen and painful 2 weeks later. I was offered the vacine in the hospital when I was there for a lacerated kidney. I told the nurse I had  one previously over 10 years ago and did not believe it was necessary to repeat &  thought it was good for life. She said no & due to being asthmatic that I should redo it. Now I have been told my reaction was severe and could be life threatening if I ever recieved one again.
Minor numbness in right side of upper lip, right-side of cheek above the lip, and and right side of nose. When I first noticed the numbness it affected only right side of upper lip and right side of tongue, but by that next morning the tongue had no numbness. The numbness has been consistent, now spanning 40 hours.
After injection, had arm pain, muscle pain in neck and upper back. Woke up late this morning feeling fatigue, dizzy , lightheaded and nausea.
On February 6, 2021, I received my first shot of the Pfizer vaccine in my left arm at a local pharmacy.  I am a fit, otherwise healthy 42 y/o woman although I did suffer an episode of Bell?s Palsy (BP) in 2016 which mostly resolved.  I felt some upper arm soreness as anticipated but no other notable effects.  Within a week or so of receiving the vaccine, I began to feel left side facial tingling and weakness, as occurred in the beginning of my 2016 BP experience (which was also on the left side).  I also experienced severe nerve pain in my left forearm which I likened to a burning toothache in my arm.  I immediately reached out to my PCP and expressed my concern.  She acknowledged it is likely my symptoms are due to the vaccine.  I spoke with my immunologist and together we discussed risks and benefits and decided it was reasonable to forego the second shot at that time.  Shortly thereafter, my left eye began constantly watering.  I visited my eye doctor who believed my symptoms were consistent with a BP episode.  My eye watered constantly from March through May.  During this time, I developed joint pain, a slight tremor in my left arm as well as an internal vibration.  The tremor was experienced while I was in motion, not at rest.  I was referred by my PCP to a neurologist who examined me and sent me for an MRI.  My MRI results are negative yet symptoms continue.  The nerve pain my forearm has become intermittent and has lessened over time.   Now, nearly 9-month post-vaccine, I continue to have paresthesia and muscle weakness in my face and arm and occasionally my knee.  The tremor and vibrations have become less frequent but continue intermittently.  I have asked at least 3 doctors to report my symptoms to VAERS but non have done so as of this date.
Tingling in left arm and down into hand and fingers. Then down into left leg and toes. Great pain - had 6 day Prednisone and 12 day Prednisone without relief.
Client given expired MMR. Physical there were no untoward veffects except having to repeat doses
Case number PHEH2013US019084, is an initial spontaneous report received from a medical assistant on 10 Sep 2013. This report refers to an 11 years old male patient. He was vaccinated with MENVEO (batch number: M12093 and expiry date: Aug 2014), at dose of 0.5 ml intramuscularly on 05 Sep 2013. MENVEO vaccine was reached 33 to 51 F overnight and vaccine did not freeze. No adverse event was reported following this administration error.
A?spontaneous?report was received to a 79-year old male patient, who received?Moderna's?COVID-19 vaccine?(mRNA-1273). he started having redness and itchiness on injection site. Patient received Moderna COVID19 vaccine on 13-Jan-2021 and on 21-Jan-2021 and he got the vaccine on his left arm as intramuscular injection. Agreed to follow up calls. Patient is calling to check on side effects. On 21-Jan-2021 he started having redness and itchiness on injection site. The patient's medical history, was not provided by the reporter. Treatment for the events were not included. Action taken with the mRNA-1273 in response to the event was not reported. The outcome of the event also was not reported.
Mother of pt states day after vaccination redness, swelling and warmth to deltoid muscle where vaccines administered.
Had a large welt around the injection site; patient said that she had swollen armpits and was running a fever the last few days.
Upper arm pain at site of injection, raised red itchy bump at site of injection, headache, fever, chills, fatigue, runny nose/congestion, achy joints
Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a six-months-old female patient who received a 0.5ml dose of vaccines ACT-HIB (batch number: C5447AA, expiry date: 21-Nov-2019 via unknown route in unknown administration site) and PENTACEL batch number, expiry date, route and administration site was not reported on 28-Feb-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccinations included was ROTAVIRUS VACCINE (ROTAVIRUS VACCINE), INFLUENZA VACCINE (INFLUENZA VACCINE), PREVNAR 13 and HEPATITIS B VACCINE (HEPATITIS B VACCINE). It was an actual medication error due to extra dose administered. A patient was administered ACTHIB and PENTACEL today, ACTHIB was not ordered but given inadvertently. No symptoms reported following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Had an antibody test come back negative; This is a spontaneous report from a contactable consumer (wife). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included immunodeficiency, leukaemia (Due to taking chemotherapy) and chemotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced had an antibody test come back negative on an unspecified date. Reporter also mentioned that her 78-year-old husband who is immunocompromised due to taking chemotherapy for leukemia received both doses of the Pfizer BioNTech COVID-19 vaccine and had an antibody test come back negative afterwards. The patient underwent lab tests and procedures which included antibody test: negative (Negative). The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1 day after receiving vaccine patient developed flu-like symptoms, shortness of breath, fatigue, muscle aches and redness/swelling at the site of injection.
breastfeeding her son (patient); rash/started to look like chicken pox/dots everywhere/itching and it had not itched until that day and it has developed on his face; then it transitioned into a measles looking rash; This is a spontaneous report from a contactable consumer (patient's mother) who reported for herself and her son (patient). This is the report for the baby. A 16-month-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), transmammary on 24Aug2021 (Lot Number: FD8448) as dose 1, single for COVID-19 immunization. Medical history included roseola which was diagnosed by the pediatrician on Jan2021 along with fever and cough also on Jan2021. The patient went to the pediatrician 3 times and never was tested for COVID. There were no concomitant medications. The patient previously received the Hep A vaccine on 04Aug2021 at 15 months old in the leg and the first dose of the MMR vaccine on an unknown date in 2021 at 12 months both for immunization. The patient's mother (reporter) received her first dose of BNT162B2 on 24Aug2021 and was breastfeeding her son (patient). After a week on an unknown date in 2021 (reported as either 31Aug2021 or 01Sep2021) the patient started developing a rash. It started to look like chicken pox. There were dots everywhere and then it transitioned into a measles looking rash, but it was not on his face. It continuously got worse. 07Sep2021 was probably the worst day. The patient's mother called her pharmacist and her son's pediatrician. He has no symptoms of being sick. The doctor said it could be related. The pharmacist said it sounds like COVID rash and that she should call and report it because there is not much research on how it reacts in breast fed patients. The rash was ongoing and has continuously worsened. It is kind of strange. He will wake up and she will think it is all better. Then it gets worse. On the day of the report, it is itching and it had not itched until that day and it has developed on his face, which is the first time the rash has been on his face. The patient's mother wanted to know if she could give him Benadryl and wanted to know if that will have an effect on the vaccine. She thinks that the patient is getting the antibodies if he is getting a rash. She was okay with the rash but wanted to know if giving the patient Benadryl would affect his antibodies. The outcome of the events was unknown. The events were reported as non-serious.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101176675 mother case
POSSIBLE UNDERAGED FOR VACCINE. CHILD DOB LISTED ON CONSENT BUT OTHER RECORD INDICATES DOB AS DIFFERENT.
No additional AE's/PQC's were reported; Caller reported a temperature excursion for PROQUAD / PROQUAD lot: T0304081 was administered to (14) patients since the excursion occurred on 7/22/2021; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 29-JUL-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 1 dosage form, lot # T0304081, expiration date reported as 07-MAR-2022 for prophylaxis (exact dose, anatomical location and route of administration were not reported).      Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 13.02 degrees of Fahrenheit (F) for 1 hour and 30 minutes. There was a previous temperature excursion reported (from 14 degrees of F to 46 degrees of F (17.95 degrees of F) for 45 minutes). No symptoms were reported by the patient since the administration.  Lot # T0304081 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). Lot # T0304081 does not match any Company product as confirmed by Lot Verification team.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA000999: US-009507513-2108USA000995: US-009507513-2108USA000996: US-009507513-2108USA000997: US-009507513-2108USA000998: US-009507513-2108USA000973: US-009507513-2108USA001007: US-009507513-2108USA001006: US-009507513-2108USA001005: US-009507513-2108USA001004: US-009507513-2108USA001002: US-009507513-2108USA001001: US-009507513-2108USA001000:
Employee came into the employee health office. Employee was suppose to receive Influenza Vaccine, unintentionally this writer grabbed a Hepatitis B vaccine from the fridge and gave that to the employee in the left deltoid, IM. Employee did not have any adverse reaction to the vaccine. Once this writer noticed she gave the incorrect vaccine the employee was contacted right away and updated on the medication error. The employee received Hepatitis B vaccine in 2013 (x 3 doses) with out any reactions. The employee denies any reactions at this time. The employee understood and is returning to get the correct, influenza vaccination at a late time.
Patient reported an abscess at the injection site occurring one month after his second dose. Patient reported having to go to the hospital to have it drained and is currently on antibiotics for it.
back spasms; This is a spontaneous report from a sponsored program a contactable consumer, the patient. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced back spasms. The clinical outcome of the back spasms was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
No side effects immediately after the vaccine.  30 hours later I developed  uticaria on my left arm. 1/15/21.   Reported to my physician, allergist.  Woke up with uticaria under gluteus 1/16/21.  Overnight developed increasing uticaria over my left arm, right side, back and gluteus, feeling quite tired. 1/17/21.  Called service I used over Christmas when I had the anaphylaxis to the shingles vaccine.  Doctor recommended I take Famotidine 20 mg 1/day which has antihistamine and can be taken with the Allegra.  Started  1/17/21.  Today, 1/18/21 very small uticaria on gluteus.  Feeling much better than I have all weekend.
soreness; stinging; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the dose on 31Dec2020, and experienced little soreness that lasted for 2 days and stinging that lasted for 2 hours. No other problems reported. The events resolved on an unspecified date.   Information about the lot/batch number has been requested.
From initial information received on 27May04 from a RN regarding an adverse event occurring in the USA it was reported that a 53 year old male pt received his first dose of YF VAX, lot number UE128AA, administered SC in the left arm and his first dose of Hep A vaccine, lot number UHA 798A6, administered IM in the right deltoid on 22Apr04. Thirty two days later, the pt experienced numbness of toes of both feet up to the ball area before both arches. Concomitant medications at the time of vaccination included daily ASA (81mg). At the time of initial report the event had not resolved. Pt's pre-existing medical conditions include penicillin allergy. From additional information received on 23Aug04 from a health care professional, it was reported that the pt received a dose of Diphtheria and Tetanus toxoids administered by the local health department on 24May04, the same day as the onset of the adverse event. The lot number, manufacturer, route and site of administration were not reported. The responsible physician's name was also provided. From additional information received on 26Aug04 through a telephone call from a health care professional, the pt reported that he had experienced numbness in his toes, which progressed to his legs and hands. He was subsequently diagnosed with Guillain Barre syndrome, which his physician felt to be related to the tetanus and diphtheria vaccine administered 24May04. The pt stated that he did not require hospitalization, but was in a wheelchair, then used a walker. He is currently on disability and using a cane. He had no information on the manufacturer or lot number for the tetanus and diphtheria vaccine. Due to medical judgement, this case was upgraded to serious (OMIC). From additional information received on 01/Nov/2004 from the reporting facility, it was reported that the Diphtheria and Tetansu Toxoids was not administered by the reporting facility, but by the local health department on 14/May/2004. The patient visit to the reporting facility was on 22/Apr/2004 where he received YR-VAX, Hepatitis A vaccine and Typhim VI (vaccination not mentioned in the previous vaccine, lot number X0482-2, administered intramuscularly in the deltoid. The physician noted as the patient's responsible physician in the medical director at the reporting facility and not the physician employed by the local health department. The patient recovery status is unknown.  20Jan05: Despite additional attempts at obtaining follow up for this case, no more information has been received. The pt's recovery status remains unk. Further information is not anticipated, this case is considered closed.
Fever (>100 F), nausea, body aches, chills, fatigue, breakthrough menstrual bleeding, polyuria and abdominal pain. Fever, fatigue, nausea, body chills/aches started the night of the vaccine and lasted 48 hours. Breakthrough bleeding started after 24 hours and lasted for 1 week. Polyuria started 24 hours after and lasted for 3 days.
went to sleep-woke w/pain-could not move rt side of body-severe pain up side of neck into jaw;physical therapy ribs on rt;pain med, pred, could not work, pain, swelling cont, lost ROM in arm, cannot drive, shooting pains, tingling;
pt recvd vax; szs w/in 48 hrs of 1st dpt;previously healthy infant;
ended up with a big blot that I ended up marking with a sharpie to make sure it didn't spread and it did not. I was given antibiotics and it went away but it still itches every once in a while.
I tested positive for COVID-19 12/22/2022 with a home test. I had a cough, headache, chills for a day, low grade fever, stuffy nose, sneezing, a little bit of body aches. I did feel miserable. My doctor prescribed Paxlovid but I did not finish it. I only took a day and a half worth of the medication. I took one pack then the next day I only took the morning dose then stopped. The medication had a metallic taste that lasted all day and had tasted like acid reflux. Drinking and eating had not gotten rid of the taste. I also experienced some irritation with my eyes during this course. After that, I just started taking generic Mucinex to help with the symptoms. Currently, I do still have a cough.
Myalgia; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Myalgia) and CHILLS (chills). At the time of the report, MYALGIA (Myalgia) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information about concomitants was provided.  No information about treatment medication was provided.
One week after patient was given his MMR, Chicken Pox, Hepatitis B and HIB vaccines, he got a fever and had a seizure that lasted for about 3 minutes. After the seizure he was not able to move his body for about one hour. His fever was not high at the time of the seizure. My daughter, who is five years old, had exactly the same reaction after her 18 month shots, except that she didn't have the temporary paralysis, again exactly one week after the shots.
Vomiting, diarrhea, 103.5 fever, muscle and joint pain, fatigue, severe chills
Patient experiencing headache approximately 5 to 10 minutes after receiving 2nd dose of Moderna COVID-19 vaccine.  Patient reports having a headache that lasted for about an hour following the 1st dose of the vaccine four weeks prior.  At 3:10pm:  HR=71  O2 sat= 98%   122/65.  At 3:21pm:  BP=119/62.  Headache subsiding.  At 3:31pm:  BP=105/59, HR=63   O2 sat=99%.  Patient clinically stable.  Patient released from clinic at 3:32pm.