chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt was given about 2.6 doses of the vaccine. The vaccine was reconstituted incorrectly with only 0.8ml of saline. Pt was still given 0.3ml injection, so we calculated she got 2.6 doses for her 2nd dose. Pt was counseled to watch for flu like symptoms for the next few days and to take tylenol or advil to prevent these symptoms. Also told her to stay hydrated. We will monitor her over the next few days. When we spoke with her about an hour after her dose, she was feeling fine.
Redness, swelling and warmth at injection site with irritability and a fever of 102F.
This case was reported by a consumer via call center representative and described the occurrence of lethargy in a 76-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose received in August 2018, refer case US2018GSK225498). On 10th October 2018, the patient received the 2nd dose of SHINGRIX. On 10th October 2018, less than a day after receiving SHINGRIX, the patient experienced lethargy and sweating. On an unknown date, the outcome of the lethargy and sweating were recovered/resolved. It was unknown if the reporter considered the lethargy and sweating to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. Later that day, after vaccination, the patient felt lethargic that lasted 3 days and had sweating that lasted for 7 days. This case has been linked with case US2018201060 (wife's case), reported by the same.
I had actually gone into the doctor for a lump on my collar bone and decided to get vaccinated while I was there. They gave me a cortisone shot in my collar bone, and then I received a flu vaccination and a COVID-19 vaccination. I started coughing and I felt like I had a horrible sore throat almost immediately after my vaccination. It was sore enough that I looked in the mirror and there were red little beads on my uvula and the top of my mouth. I called the doctor after I saw the spots, my throat was burning so bad it felt infected. The doctor on call prescribed a 5 day course of antibiotics. It still hasn't resolved, I still have the spots and the burning. I did have some recent moving around of hoarded items from my deceased husband, its possible that some of the dust irritated me, but I don't know if that would account for the red spots. I've also been really weak and tired. I still have the coughing and sore throat and fatigue, and a slight runny nose.
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided.
Pt began with right shoulder shrugging and has continued. Seen at ER 4/17/2015. Episodes are currently 1-2 times per hour, was >40 times per day. No episodes known during sleep. Seen by Neurologist, EEG done and within normal limits.
This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 70 or 71 years old. The patient presented with guillain barre syndrome and was referred to a neurologist for further evaluation. There were no other circumstances to make her think it was attributed to anything else. Neurologist was treating for guillain barre syndrome according to the reporter. The reporter agreed to be followed up from GlaxoSmithKline. No other information was known.
Information has been received from a consumer concerning a male with a history of shingles and no allergies who in 2007 was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that the patient experienced muscle spasms on right side of face.  No medical attention was sought.  A product quality complaint was not involved.  No further information is available.
2-3 min post vaccination patient had syncopal episode with 1 min of complete unresponsiveness and absence of pulse, associated diaphoresis.  He did not develop any stridor or wheezing or rash.  This same response occurred with initial covid vaccine approximately 7 months prior to this event.  He was at that time diagnosed with vasovagal syncope after extensive work up at ER with echo, EKG, CT and blood work which was normal.  He has not had previous syncopal episodes with blood draws or other injections. He receives the flu shot every year without near syncope.  I believe this was an anaphylactic response due to previous similar presentation with  initial covid vaccine in feb 2021
Difficulty breathing; Weak; Cough; Fatigue; 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 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), ASTHENIA (Weak), COUGH (Cough) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), ASTHENIA (Weak), COUGH (Cough) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Difficulty breathing), ASTHENIA (Weak), COUGH (Cough) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Severe headache, dizziness, muscle aches, fever 99.9, nausea, stomach ache and ice cold. Did not seek treatment. Rested at home.
arm got red; arm swelling; arm got bruising; arm got itchy; A spontaneous report was received from a consumer concerning a patient, who received Moderna COVID-19 vaccine (mRNA-1273) and experienced injection site redness, swelling bruising and itchy. The patient's medical history was not provided. No relevant concomitant medications was reported. On 6-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot number :unknown) intramuscularly  for the prophylaxis of COVID-19 infection. On an unknown date , the patient experienced injection site redness, swelling bruising and itchy. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of report, the outcome of the events injection site redness, swelling bruising and itchy was unknown.
Menstrual cycle was due to start on 1/14, but was over 1 week late. Was not pregnant.  2nd dose was administered on 1/26/21 lot EL1284.   Became pregnant the next month and miscarried at 6 weeks. Had a second miscarriage in July 2021 and baby?s heart stopped at 11 weeks.
This spontaneous report was received from a physician regarding a 11 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions and concomitant medications were not reported. On 09-SEP-2016, the patient was vaccinated with unidentified Merck hpv vaccine GARDASIL or GARDASIL 9 (dosing details and route of administration unknown) lot# reported as L053214 and expiration date 30-AUG-2017 for prophylaxis when refrigerator was out of range(Incorrect product storage). Lot number L053214 is an invalid lot number for GARDASIL or GARDASIL 9. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA004718: US-009507513-1701USA004719: US-009507513-1701USA004720: US-009507513-1701USA004721: US-009507513-1701USA004722: US-009507513-1701USA004723: US-009507513-1701USA004724: US-009507513-1701USA004725: US-009507513-1701USA004726: US-009507513-1701USA004566.
Pt.received a Pfizer Covid vaccination but was supposed to receive a Shingrix vaccine.   He received his Covid series (Moderna) 1/22/21 and 2/19/21.  This was a third Covid vaccine and unnecessary. He experienced a sore arm for approximately 2 days. He did not experience fatigue or headache. He did experience chills and hotness (fever?) for 3 days. His doctor was notified by me, pharmacist and he recommended the shingrix shot 2 weeks after this Covid shot. He is not currently experiencing side effects.
Patient now has seizures with fever. She has been sick numerous times prior to the vaccine and never had seizures and now when she has even a low grade fever (100) she seizes
develops shingles; first Shingrix vaccination a few years ago; This case was reported by a physician via call center representative and described the occurrence of shingles in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, several years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the 1st dose of Shingrix vaccination a few years ago and now developed shingles. The reporter enquired if there was a value in getting a booster Shingrix shot. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination.  No further details provided via web form. The reporter consented to follow up.
minor erythema w/tenderness surrounding site of DT inject; no sign of infect look like inflammatory react; no documantation on where whom gave vax; pt came to ER for eval inject not given here;
had a bad headache and brain fog for 3 days; had a bad headache and brain fog for 3 days; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), FEELING ABNORMAL (non-serious), outcome "recovered" and all described as "had a bad headache and brain fog for 3 days". Additional information: Patient was the physician. Says after dose 1 of COVID vaccine had a bad headache and brain fog for 3 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills, body aches, migraine headache, nausea. Nausea has continued to be a big issue from the night of injection until today, which is Monday, 3/29/2021.   On Saturday night (3/27) I experienced overwhelming stomach pain and nearly passed out on my toilet multiple times during a bout of diarrhea.
Pt recvd 3rd dose of Hep B vax ID instead of IM; Subsequently, pt devel a "local reaction";
Client was observing her sibling receive a vaccine. Client then had a  vasolvagal response about 5 minutes after her COVID-19 vaccine. She fell to the ground and hit her head. The client become oriented seconds after the event occurred. No visible trauma was observed. Both parents were in the room at time of the event.
4/15/03 Woke up at 4:30 AM "feeling bad" - temp not taken - Tylenol given - child went back to sleep. 8:00 AM mother notice right arm red and swollen and is getting worse. Advised to apply cold compresses today and warm compresses tomorrow - if no better, see MD.
2cm palpable nodule on left deltoid, with annular red area. The center has a 0.5cm open area that is dry with no drainage but is black in color. The area was painful to touch and warm to touch and swelling was present.
She was sick; COVID-19 Disease Symptoms after First vaccine/ Positive PCR after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 Disease Symptoms after First vaccine/ Positive PCR after first vaccine) and MALAISE (She was sick) 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 information was reported.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 Disease Symptoms after First vaccine/ Positive PCR after first vaccine). On 06-May-2021, the patient experienced MALAISE (She was sick). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 Disease Symptoms after First vaccine/ Positive PCR after first vaccine) and MALAISE (She was sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, COVID-19: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medication information were not provided.   Reporter did not allow further contact
I had a sore throat, headache, fatigue, sinus pain, and fever. I only been sick for a couple of days.
Pt had diffuse myalgias beginning the day after the vaccination. CK level, BMP, CBC unremarkable, no other acute illness appears to be present to explain this. He does have longstanding psoriasis with likely psoriatic arthritis which could easily be a confounding factor.
Information has been received from a registered nurse (R.N.) concerning a 3 year old male who was vaccinated with the 2nd dose of VARIVAX (Oka/Merck). On 30-APR-2008 the patient had a chickenpox breakthrough. AT the time of report, it was unknown if the patient recovered or not. Follow up information was received which reported that a 4 (previous reported a 3) year old male who on 05-APR-2005 was vaccinated subcutaneously with a first dose of VARIVAX (Oka/Merck) in his left thigh. On 04-FEB-2008 the patient was vaccinated subcutaneously with a second dose of VARIVAX (Oka/Merck) (lot #658935/1349U) in the right thigh. On 02-MAY-2008, the patient developed classical symptoms of chickenpox which was verified by the physician. At the time of report, the patient recovered. No further information is expected.
Patient report arm swelling and tenderness/pain at site of injection. Patient went to seek medical attention.
This spontaneous report as received from a pharmacist refers to a 66 year old male patient. On 28-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # H021710, expiration date 07-MAR-2014, (dose was not reported), subcutaneous in the right arm. At that same time the patient was also vaccinated with a dose of PNEUMOVAX 23 (dose, route and frequency were not reported), in the left arm. In July 2013 the patient developed 3 inch rash at the ZOSTAVAX injection site of the right arm and body ache. The patient was not hospitalized and it was not life threatening. The patient was checked by his physician and was placed on over the counter BENADRYL. The reporter stated that the patient was feeling better (at the time of the report). The relatedness between the events and ZOSTAVAX, PNEUMOVAX 23 was not reported. This case is linked with case MARRS# 1308USA000698, considered the same reporter. Additional information has been requested.
Decreased appetite & fussiness for 2 weeks following vaccines. 3 days after vaccines had emesis & fever 103 for a day.
Looked like blisters; Hives; Severe itching arms, torso, back of legs; He had a very bad rash all over his body, on arms, torso, and back of legs; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Looked like blisters), URTICARIA (Hives), PRURITUS (Severe itching arms, torso, back of legs) and RASH (He had a very bad rash all over his body, on arms, torso, and back of legs) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2022, the patient experienced BLISTER (Looked like blisters), URTICARIA (Hives), PRURITUS (Severe itching arms, torso, back of legs) and RASH (He had a very bad rash all over his body, on arms, torso, and back of legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and CAMPHOR, MENTHOL, PHENOL (SARNA [CAMPHOR;MENTHOL;PHENOL]) at an unspecified dose and frequency. At the time of the report, BLISTER (Looked like blisters), URTICARIA (Hives), PRURITUS (Severe itching arms, torso, back of legs) and RASH (He had a very bad rash all over his body, on arms, torso, and back of legs) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. He used Benadryl on his own which did not help. He has to take more than therapeutic amount of Zyrtec, for the itching to improve. He is still taking the antihistamine and using the Sarna lotion. Wife does not remember if her husband had a rash after the second vaccine.   This case was linked to MOD-2022-487118 (Patient Link).
Pt came in for Moderna booster (half dose) after about 3 mins of received shot Pt complained of dizziness and blurred vision. Took Pt back into vaccine room pt became pale, complained also about nausea, paleness caused shallow breathing, numbness of hands. on the form pt did not say that she had rxn to prev covid vaccine (or any other vaccine) in general, also when I asked open ended question pt did not say she has reaction before- in the room pt mom and pt mentioned that these same exact sx happened after 2nd dose but this dose even worse. pt did not want to have anything to eat or drink. pt said this happened to her after 2nd shot as well, but it is worse this time. we fanned her and provided icepacks to cool her down. asked pt if she wanted me to call 911 and she said yes, told them that they may be charged and mother said that it is ok b/c they have insurance. emt came in and took vitals, they said that everything is normal and that they can go to hospital if she wants. they said she might be scared of vaccine and had vasoreactive reaction. pt felt much better and was able to walk on her own. pt mother said that she will not be taking her to ER.
Erythema, swelling, pain at the site of vaccine within a few hours of the shot. Advised for TYLENOL/ibuprofen, icing.
RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/11/21. ON 02/18/21 WENT FOR BURNING WITH URINATION AND DIAGNOSED WITH ACUTE UTI.  ON 2/19/21 CALL  REQUESTING CHANGE IN ANTIBIOTIC FOR UTI. LATER ON MESSAGE SENT ABOUT URINE CULTURE SUGGESTING NOT A TRUE UTI.  ON 02/21/21 WENT ER COMPLAINING OF DYSURIA, RT FLANK & BACK PAIN. DIAGNOSED WITH LOWER ABDOMINAL AND CVA PAIN AND INSTRUCTED TO FOLLOW UP WITH UROLOGY.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 58-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 31st July 2019) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information received as follows: The healthcare professional did not know how soon after the vaccine that the patient developed the shingles.
Presented to the ED c/o SOB/dysphagia; admitted for pna d/t COVID-19; tx w/O2, singulair, zinc, steroids, abx; weaned to RA, dc'd home
rash, raised & bright red hives on arms & inner thighs & back of legs;fever 101 & achy;
Unsure if side effect of vaccine but experiencing sweating, abdominal cramps and diarrhea.; Unsure if side effect of vaccine but experiencing sweating, abdominal cramps and diarrhea.; Unsure if side effect of vaccine but experiencing sweating, abdominal cramps and diarrhea.; This is a spontaneous report from a contactable Nurse.  A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot and batch number unknown) via an unspecified route of administration at an unknown dose in the right arm on 23Dec2020 at 12:45 (at the age of 41-years-old) for COVID-19 immunization. Medical history included asthma, anxiety, arthritis, fibromyalgia and surgical menopause all from unknown dates and unknown if ongoing. The patient did not have any allergies to medications, food or other products. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccination in the hospital. Concomitant medication included meloxicam (MELOXICAM), estradiol (ESTRADIOL), gabapentin (GABAPENTIN), phentermine (PHENTERMINE), melatonin (MELATONIN), aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX), collagen (COLLAGEN). The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient stated that she was unsure if these were side effect of vaccine but on 25Dec2020 at 10:00 she was experiencing sweating, abdominal cramps and diarrhea. The clinical outcomes of sweating, abdominal cramps and diarrhea were reported as recovering. It was also reported that since the vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.