chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body tremor/body shakes without temperature/her hands very shaky; Coughing; Creaky sounding voice; Slept alot that day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Creaky sounding voice), HYPERSOMNIA (Slept alot that day), COUGH (Coughing) and TREMOR (Body tremor/body shakes without temperature/her hands very shaky) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for an unknown indication.     Concurrent medical conditions included Myasthenia gravis.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced DYSPHONIA (Creaky sounding voice) and HYPERSOMNIA (Slept alot that day). On 23-Feb-2021, the patient experienced COUGH (Coughing). On 24-Feb-2021, the patient experienced TREMOR (Body tremor/body shakes without temperature/her hands very shaky). At the time of the report, DYSPHONIA (Creaky sounding voice), HYPERSOMNIA (Slept alot that day) and COUGH (Coughing) outcome was unknown and TREMOR (Body tremor/body shakes without temperature/her hands very shaky) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's medical condition of myasthenia gravis and advanced age are contributing factors.   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 event, a causal relationship cannot be excluded.  The patient's medical condition of myasthenia gravis and advanced age are contributing factors.
Severe muscle spasms in lower back, treated with Tylenol, ice pack, heat pack, CBD cream, rest, chiropractic adjustment.  Slow improvement over the course of 4 days (day 5 since vaccine still minor inflammation/pain at low back)
RASH UNDER LEFT AND RIGHT ARM STARTING ON THURSDAY  02/25/2021 VERY ITCHY, RED AND IRRITATED SKIN. STARTED WITH A LITTLE SPOT UNDER AXILAR, BUT EVERY DAY WAS EXPANDED MORE AND MORE. WENT TO THE EMERGENCY ROOM ON 03/01/2021 MORNING 8:39AM DOCTOR DIAGNOSE "IRRITANT CONTACT DERMATITIS DUE TO OTHER AGENTS'. THE ONLY TEST  I GOT THERE WAS SUGAR BLOOD (RESULT NORMAL 97%) PRESCRIBE ONLY 'HYDROCORTIZONE CREAM" TWICE DAILY. DIDN'T HELP TODAY IS 03/03/2021 AND IS GETTING WORSE, THE AREA IS BIGGER UNDER ARM BRASS LINE, ON THE ARM AND ALSO IN PART  OF MY BREAST. CALL TO EMERGENCY ROOM TO SEE WHAT TO DO? AND NOT A GOOD ANSWER JUST TO CALL A DERMATOLOGIST.
they did not put the Shingrix in the proper refrigerated storage conditions; blisters; Suspected Vaccination Failure; Shingles outbreak; Severe burning pain; Loss of sleep; Loss of function in an extremity; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2018, the patient received the 1st dose of Shingrix. On 11th September 2018, the patient received the 2nd dose of Shingrix. On 25th October 2019, 1 year and 114 days after receiving Shingrix and 1 year and 44 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain burning, sleep loss and upper extremity dysfunction. On 27th October 2019, the patient experienced blister. On an unknown date, the patient experienced incorrect storage of drug. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles, pain burning, sleep loss, upper extremity dysfunction, blister and incorrect storage of drug were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain burning, sleep loss, upper extremity dysfunction and blister to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left deltoid. On 25th October 2019, the patient began experiencing shingles symptoms that progressed on the 27th October 2019 to blisters.  The patient reported stated she felt her shingles episode was severe with burning pain in the right arm and hand with a loss of function and sleep. The patient was under the treatment of a provider for the outbreak and has been prescribed Valtrex. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation for shingles were not provided. The patient also stated she overheard the pharmacist telling employees that they did not put the Shingrix in the proper refrigerated storage conditions.  The patient asked question about the viability of the vaccine she received. The reported consented to follow up.
Itching, pins and needles, aches, cold like symptoms, seizure like movements during sleep. During first few weeks after flu shot severe fatigue and discomfort and pain due to the symptoms.
Patient called the office at 4:16pm stating he was having extreme pain and swelling in his arm that he received the vaccination in.
Loss of consciousness, developed heart rate below 38, unresponsive to ammonia inhalants and trundle position 2 minute seizure noted prior to administration of epinephrine. 911 called. Pt transported  via Ambulance to ER.
Pt reports she noticed a "knot" at injection site 12 hours after MMR injection administered LA SC on 4-23-03.  5-1-03 she stated that she experienced flu like symptoms, swelling in the left axilla, 2 small clusters of "blisters", "no fever", and that the indurated area was "about half the size of a golf ball and hot on 4-30-03".  5-1-03 she stated that she developed a "head ache and fever of 100 degrees by noon", "felt even weaker" and that there was a "gray blue bruised looking area now surrounding the blisters".  "Nausea but no vomitting". Pt states she was seen at a clinic and that she was given "Levoquin 500mg po x 7 d, Phenergan Suppositories, and 50mg of Benadryl".  "Blood work and ECG were normal except for increased heart rate as I was anxious".  She states that the clinician instructed her to cover the site with a warm wash cloth and wrap saran wrap around the site.  Pt was seen by PCP on 5-2-03 who reportedly diagnosed MMR reaction and cellulitis.  Pt received injection of Rocephin 500mg.  She reported that the swelling of the left axilla was "a little better".
sore; Shoulder pain; Warm; At injection itching; At injection inflamation; Red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (At injection itching), VACCINATION SITE REACTION (At injection inflamation), VACCINATION SITE ERYTHEMA (Red), FEELING HOT (Warm) and PAIN (sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced INJECTION SITE PRURITUS (At injection itching), VACCINATION SITE REACTION (At injection inflamation) and VACCINATION SITE ERYTHEMA (Red). On 03-Feb-2021, the patient experienced FEELING HOT (Warm). On 17-Feb-2021, the patient experienced PAIN (sore) and ARTHRALGIA (Shoulder pain). The patient was treated with HYDROGEN PEROXIDE (PEROXIDE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (At injection itching), VACCINATION SITE REACTION (At injection inflamation), VACCINATION SITE ERYTHEMA (Red), FEELING HOT (Warm), PAIN (sore) and ARTHRALGIA (Shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Approximately 20-30 minutes after receiving the vaccine left arm became slightly numb, noticeable during the short 10 minute drive home. Within 30 minutes of getting home there was notable numbness in the left arm, especially below the elbow and into the hand with last two fingers being the most affected; numbness was also up into the neck and felt in the left cheek/jaw up to near the left ear and the scalp. This diminished over the course of the evening. The next two days there was lingering soreness in the left neck from where neck meets shoulder and slight tingling in the last two fingers. Ibuprofen 600 mg was taken to assist with any pain, usually in the morning with other medication before going to work. By two to three days after the vaccination there was no more soreness or numbness. While no bruising ever occurred, firm pressure on the site of injection two weeks later is still mildly painful.
left arm redness, swelling and slight itching. Treatment with Benadryl and cool compresses.
Headache, NauseaVomiting, fatigue, lymphadenopathy, runny nose Narrative:  patient took tylenol and zofran
On 10MAR92 or 11MAR92 (mom unsure) state pt very quiet, mouth & hands clenched, birth mark purple; cont to have episodes & was taken to MD on 14MAR92; dx seizures; consult done w/MD & phenobarbitol ordered;
Booster after positive COVID test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Booster after positive COVID test) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Booster after positive COVID test). At the time of the report, COVID-19 (Booster after positive COVID test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The reporter wanted to enquire what was the wait time to receive 2nd booster, after a positive COVID test.  No concomitant medication reported. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2023: Case MOD-2023-706687 was created with IRD 01-Feb-2023 and SRD 02-Feb-2023 which was received via portal however an Email was received from consumer to Media team of Moderna on 31-Jan-2023 which was forwarded to drug safety team on 03-Feb-2023, hence a new initial case was created capturing IRD as 31-Jan-2023 and SRD 03-Feb-2023 and FU was appended dated 01-Feb-2023 (which was received via portal) with ID MOD-2023-707437 hence case  MOD-2023-706687 with IRD 01-Feb-2023 and SRD 02-Feb-2023 was deleted from safety database and case MOD-2023-707437 was retained for further follow-up.
Pt states that she received her vaccination at 10:00am and felt chest tightness immediately.  This resolved within minutes and pt left testing site.  Pt states that around 11:00am she felt numbness and tingling in her bilateral forearms and fingers.  By 11:45 when we spoke, the numbness and tingling had improved but was still present.
Patient reported pain, swelling and redness at the injection site the next morning, 48 hours later, his red, swollen area was 9 cm long and 10cm wide. He was referred to his primary care doctor.
Flushing of cheeks, neck, arms; reported felt hot. Epinephrine 0.2 mg IM with monitoring X 25 minutes. Symptoms resolved; Refused EMS. 24 hours later, symptoms returned, required EMS transport to ER.
2 months after receiving second shot, developed itchy rash with small bumps  on lower left side of torso.  Over time rash spread to other parts of torso.  After 2 months treating with anti-itch creams, consulted dermatologist.  Discussed changes in medication, diet, clothing, and environment conditions.  Cause of rash not readily identified because of no changes.  Doctor related that there have been anecdotal reports of post-vaccine rash.  Prescribed steroid cream that has provided relief for itching and rash.  Rash appears to have been resolved for the most part as of this date.
my entire body started screaming in pain, every bone, every nerve, on a scale of 1-10, it was way out of 10; My shoulder started hurting; chills; temperature was 101F; A spontaneous report  was received from a (Physician ) concerning a  85 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  my shoulder started hurting/Arthralgia, my entire body started screaming in pain, every bone, every nerve, On a scale of 1-10, it was way out of 10/Pain, Chills and temperature was 101F/Pyrexia  The patient's medical history included as she had the virus but was asymptomatic. Her test came positive. No relevant concomitant medications were reported.    On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced my shoulder started hurting, my entire body started screaming in pain, every bone-every nerve, On a scale of 1-10, it was way out of 10/Pain, was serious event, Chills and temperature was 101F.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events were Not Resolved/Not Recovered.; Reporter's Comments: This case concerns an 85-year-old female, with PMH of COVID-19, who experienced a serious unexpected event of severe pain along with nonserious expected fever, chills, arthralgia.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
had the shingrix shot (second one) on 11/15/2019. that night I got chills, them went into the sweats and got very weak. got diarea and my arm sweated where I got the shot. It was perhaps the worst I have felt in my life. I had a similar reaction but not as bad on the first one.
After receiving the first Pfizer vaccine, I am unable to make an appointment for the second injection.
Within 2 hrs of the 1st covid vaccine, neck glands were so swollen and painful POUNDING HEADACHE and dizziness. FOUR asthma attacks that night about 40 minutes a part.  The headache started to dissipate when it was time to get the 2nd shot 4/24/21 same location as the first EN5318 . The POUNDING headache returned with a vengeance. That continued for approximately 2 weeks still dizzy.  On 5/11/2021 Woke up with 102 fever pounding headache exhaustion and dizziness. This last 24 hours. STILL DIZZINESS continued. On 6/1/2021 EXTREME SHARP ROLLING pain that starts in my neck travels up the side of my head and ear caused me to scream-I take an asprin. On 6/4/2021 I blurt out the word cucumber no reason no through process( brain damage) then 6/4/21, 6/5/21 ,6/6/21 I call my grandson all weekend. THIS IS NOT HIS NAME. I finally can get in to see my doctor on 7/6/21 he is concerned and refers me to a Neuro. Dr FINALLY has an opening on 8/21/21 She orders a brain MRI and EEG.  Working diagnosis  ,".....her symptoms complex highly suggestive of POST VACCINE ASEPTIC MENINGITIS..."
Woke up at 3 am and could not rest on right arm too painful pain radiates and still does 12 hours later up and down entire right side arm neck to ear . Woke up again at 8! sneezing only right side sneezes lasted 3 hours sneezing constantly finally  2 pump in both nostril zicam nasal spray. But started back up nose dripping ... headache ... no fever ,
Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular at left arm on 13Feb2021 at 10:30 am (lot number: EN9809) (age at vaccination 52-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included COVID-19 with lost of smell and taste on 18Dec2020. The patient laboratory investigations included COVID test was positive on 18Dec2020 and 31Dec2020. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, was the patient was diagnosed with COVID-19. The patient medical history and concomitant medications were none. Since the vaccination, has the patient not been tested for COVID-19. The patient experienced soreness at injection site on 13Feb2021. The patient had not received any treatment for the events. The outcome of the events was recovered. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular at left arm on 06Mar2021 at 5:00 pm (lot number: EN6206) as dose 2, single for COVID-19 immunisation.  Follow-up attempts are completed. No further information is expected.
Patient had a delayed onset cutaneous reaction of intermittent urticaria that would resolve with Zyrtec and reoccur spontaneously the next day.  She has had continuous recurrence daily since the onset of the adverse event.  Hives and dermatographia have occurred regularly.  Does not have a history of allergies or adverse reactions to vaccines.
Patient reports low grade fever (100.7 F), with flu-like symptoms (myalgia, fatigue, malaise) 8-23 hours following vaccine administration. These symptoms were not experienced following the first dose in the series.
BLOOD CLOT; This spontaneous report received from a consumer via social media through a company representative and concerned a patient of unspecified age and sex The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot three weeks later without any underlying conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210504574.; Sender's Comments: V0:20210503763-Covid-19 vaccine ad26.cov2.s-Blood clot. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
after flu shot administration patient reported pain that was radiating to his fingers and he said it was getting better.  He later called back saying he was still experiencing pain and he spoke to his primary doctor.
Patient came to ED for increased shortness of breath.  Patient was admitted to hospital and did have respiratory failure and have to be intubated.  Patient did not survive.
administered infanrix/, Date of birth Jul 28th 2009; administered infanrix/ Boostrix was the vaccine indicated; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: A health care professional administered Infanrix to a patient of age 12 years old, instead Boostrix was the vaccine indicated for the patient, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This case was 1 of 7 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201377:same reporter US-GLAXOSMITHKLINE-US2021201373:same reporter US-GLAXOSMITHKLINE-US2021201375:same reporter US-GLAXOSMITHKLINE-US2021201376:same reporter US-GLAXOSMITHKLINE-US2021201380:same reporter US-GLAXOSMITHKLINE-US2021201379:same reporter
Information has been received from a pharmacist concerning her infant daughter with no pertinent medical history or drug allergies who on 28-JUN-2007 and 30-OCT-2007 was vaccinated PO with the first and third 2.0 ml doses of Rotateq. There was no concomitant medication. In approximately 2007 after the first and second doses of Rotateq, the patient experienced immediate vomiting. Subsequently the patient recovered. On 30-OCT-2007 in the evening the patient experienced a delayed response of vomiting 3 days in a row since and was a little fussy. It was noted that the patient had no fever. The patient did not seek medical attention. No labs or diagnostic studies were performed. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested.
Redness in (R) arm. Area size 4 1/2 x 5 1/2 cm. where varicella injection was given. No distress noted. Reaction occurred same day. Pt returned to our office on 3rd day after shot BENADRYL TID x 1 wk was advised as well as cold compress TID.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. None pertinent medical history, drug reactions or allergies were reported. On 24-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # K009199, expiration date 27-SEP-2015, 0.65 ml, subcutaneous (dose number and anatomical location were not reproted). None concomitant therapies were reported. On 25-OCT-2014, 24 hours after vaccination, the patient's entire body was itching. The patient was seen in an unspecified urgent care center and was prescribed prednisone (manufacturer unknown). No rash reported. The outcome of the event was unspecified. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
48 hours post vax, the pt developed a diffuse papular rash on arms and abdomen. Relief with Benadryl. Full resolution.
Had fatigue, fever, chills, HA, nausea, evening vaccine given. Redness around vaccine site involving upper arm to elbow. Fever to 100 degrees F.
Patient received duplicate varicella vaccine 1 week after receiving original vaccine. On the evening of duplicate vaccine he began having fever. Later encounter in office on 9/17/18 showed he had herpangina. This was not thought to be related to vaccine.