chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since receiving the first dose Vaccine, has been experiencing extreme fatigue; The caller feels like she has been drinking.; Had a few headaches/ The caller gets dull headaches and they are persisting.; dizziness like feeling; This is a spontaneous report from a Pfizer-sponsored program. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0185) (age at vaccination 55-year-old), dose 1 via an unspecified route of administration, administered in deltoid left on 22Jun2021 1at 0:45 as dose 1, single for covid-19 immunisation. The patient medical history (including any illness at time of vaccination) and concomitant medications were not reported. Patient did not known regarding family medical history relevant to AEs. Patient did not have additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the first administration date of the suspect vaccine. Patient did not experience any AE prior vaccinations. It was reported that, since receiving the first dose Vaccine, had been experiencing extreme fatigue. The caller feels like she had been drinking. Patient couldn't say exactly when this began. The patient states that she received the first dose Pfizer Covid 19 Vaccine on 22Jun2021, and this began in just a day or a couple of days after. The patient states the extreme fatigue had not gone away and was not good. The fatigue was moderate to severe and it was persisting. The fatigue kind of started like it ramped up if you know what the caller was saying. It was a bell shaped curve within a few days. The headaches began within a couple of days of receiving the first dose Pfizer Covid 19 Vaccine it seems like. The patient gets dull headaches and they were persisting. The patient states she went into the doctor office today, 15JUL2021 and was going to wait until next week to do some labs. The patient clarifies she just called the doctor's office today. Relevant Tests was reported as none. The reporter states that the Pfizer Covid 19 Vaccine was already drawn up that the patient received and asks was this bizarre? The outcome of event she has been drinking was unknown and for rest of the events was reported as Not recovered.  No follow-up attempts are possible. No further information is expected.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 30th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given to patient. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:case
p/vax pt exp herpes zoster w/quite a lot of pain in the area of lesions;pt was initially seen by a pediatrician & was referred to dermatologist for addtl tx;
Red, inflamed around injection site. 8 days after vaccine. cleared within 1 day
This spontaneous report was received from a certified medical assistant concerning to a 14 year old patient of unknown gender. No medical history, concurrent conditions or concomitant therapies were reported. On an unknown dates, the patient was vaccinated with the first and second dose of GARDASIL (dose, strength, route of administration and lot number were not provided). On 03-NOV-2015, the patient was in the reporter's office to receive the third dose of the vaccines series with GARDAIL 9, lot number L000610 with expiration date 31-JAN-2017 (dose, strength, route of administration were not provided). No adverse effects were reported. Additional information has been requested.
"COVID arm" = very painful (painful to touch), redness (purple tint), itchy
This case was reported by a other health professional via sales rep and described the occurrence of cellulitis in a patient who received MENVEO (batch number M15098, expiry date unknown). On an unknown date, the patient received MENVEO. On an unknown date, an unknown time after receiving MENVEO, the patient experienced cellulitis (serious criteria GSK medically significant). The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to MENVEO. Additional details were provided as follows: The patient received MENVEO on an unknown arm. The age at vaccination was not provided. This case was linked to case US2016GSK137626, reported by the same reporter.
I?m still not sure what to make of my reaction. Started to feel ?out of body?, slow and had left-sided chest pain at around 8 minutes after administration. Then flagged down a nurse. They checked my blood pressure at 196/110 (first one may have been 210/110)- I was sort of disoriented. Sat there for about an hour with repeated blood pressure checks, until my pulse went from 118 down to 90. They let me go home at 170/100. I do t have hypertension. Then went and laid down in my office nearby and my left upper arm turned bright red and became painful and slightly swollen. Took five hours for my blood pressure to drop to 118/80- my normal is 114/78. Still have weird chest pain and some SOB with exertion (not normal for me).
red like a rash; heart rate for 1 minute or 1.5 minutes went up to 209 bpm; dizzy; extremely exhausted; nauseous; lack of appetite; had a little bit of fever, a 99.3°F~99.4°F fever; Pain in left jaw -pretty intense; Lips and cheeks were numb; Lips and cheeks were numb; Numb mouth; This is a spontaneous report from a contactable consumer (patient herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number ER8732, Expiry date: 31Jul2021, Age at vaccination: 44years) via an unspecified route of administration on 27Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain in left jaw -pretty intense, red like a rash, heart rate for 1 minute or 1.5 minutes went up to 209 bpm, dizzy, extremely exhausted, nauseous, lack of appetite, had a little bit of fever, a 99.3 degree F 99.4 degree F fever. On 27Mar2021 it was reported that patient lips and cheeks were numb, numb mouth. She got received the vaccine on Saturday and 20 mins after received it my mouth, cheeks and lips got numb little numb, pretty strong jaw king in my left jaw joints, her face when she looked into the mirror was blushy and red. It was weird, she don't know. Seems like she was fine, after that, after a while, 2 days later, she felt extremely high heart rate of about 209 or some around 200 for she don't know exactly about the whole time but for a minute or minute and a half and I got completely exhausted and nauseous she did have very mild temperature like 99.4 or something like that and she have read on the internet that If you have any reaction then you should probably get allergy tested and also perhaps not receive the second vaccine but she really would like to receive it but she need to check that there is something considered as allergic reaction. The outcome of the events was unknown.  Follow-up (PRD 02Apr2021/ SRD 09Apr2021) New information was received from a contactable consumer includes: lot number, expiry date, events onset date.  No follow-up attempts are possible. No further information is expected.
Patient is a 85 y.o. male patient of MD with history of Parkinsons,  CAD,  Chronic Back and hip pain,  Depression, BPH, Edema, HTN  presented to Hospital with unwitnessed fall .   Acute hypoxic respiratory failure d/t COVID 19 infection Atelectasis  Tested + for covid 3/21/23, exposed to other residents  Has mild cough and ST  Febrile on arrival (Tmax 100.4), HR 76, RR 18, BP 117/73, satting mid 80s on RA CBC with mild leukopenia (Wbc 3.83). CRP 44.1. LA 1.2. VBG 7.38/46  CXR without vascular congestion or consolidation CTPA w/o PE or airspace disease. Noted atelectasis Cont PO decadron, holding off on Remdesivir IS/PEP, mucinex Now off oxygen and satting in mid 90s on RA Discharged in stable condition, return precautions discussed Patient instructed to follow up with PCP      Unwitnessed mechanical fall Closed Head injury Elevated CPK Reported fell overnight and was on ground for hours CPK 402 CT head negative CT cervical, thoracic spine no acute fracture CT abdomen pelvis/chest no fractures Fall risk precautions PT/OT/CM for discharge planning Set up with home therapy    Parkinsons Disease complicated by hallucinations  Follows with Dr neurology  Continue Carbidopa/Levodopa Continue seroquel   HTN Edema  CAD Follows with Dr  Has moderated 3 vessel disease  BP controlled on admission Troponin normal, EKG no ischemia  Hold diuretics with AKI, resume when appropriate Continue metoprolol    BPH with LUTS Follows with urology Continue flomax and ditropan    Chronic Back Pain  Follows with Dr   Resume oxycodone, Gabapentin  Database history reviewed
Mother called into Health Dept on 09/07/2005 and talked to RN. Mother reports that her son's lt arm was swollen 3 times normal. Denies that he had any fever but that he complained that it was stiff. Mother states that it lasted for 3 days. She states that she gave tylenol and applied a cool compress.
Severe muscle spasms in back from cervical region to sacral region.  Feels completely locked up, I can't turn or bend.  Cannot find a comfortable position and still in severe pain 3 days later with pain meds and muscle relaxers.
Woke up 5 AM on 5/27/09 T 102 Crying unconsolable - vomited X T - ate only 5 grapes - Temp 102.6 ax in office at 11:30 AM on 5/27/09.  Physical exam normal in office, CBC performed nml.  Exam yields tenderness at injection site with mild guarding.  Final dx was Vaccine Reaction.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LOOKS TERRIBLE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total, administered on SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced not feeling well, looks terrible and reported positive to PCR (polymerase chain reaction) tests (suspected clinical vaccination failure, suspected covid-19 infection). The action taken with covid-19 vaccine was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and looks terrible was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211018993. This report was associated with Product quality complaint.; Sender's Comments: V0: 20211021857-Covid-19 vaccine - Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
On 7/6/19 (Saturday), patient received a Shingrix shot in the left deltoid muscle. On 7/9/19 (Tuesday)  pt came to pharmcay asking for advise. He reported his arm was swollen, red and hot to the touch. Rph asked to see the arm. There was a band-aid on the arm> Rph asked if that band-aid was the band-aid he received on Saturday? Pt said yes. Rph asked pt to remove bandaid, to see if the site of injection looked infected. The skin looked fine. There was indeed a red swollen lump below the injection site and was hot to touch. On questioning, pt said he did not have any reaction,except a sore muscle on Saturday. Then suddenly on Tuesday morning, he awoke with a red swollen lump on his left upper arm, was concerned and came to pharmacy. Rph reffered pt to be checked by his PCP.
Pt received shingrix shot on 9/14/19.  This is second shot, was sore for about 4 days.  Received 2nd shot.  Within 24 hours got red, about 3 inch diameter red spot.  Warm to the touch.  The redness is bright red and the red part is swollen.  Pt has taken ibuprofen and Tylenol to relieve discomfort.
Symptoms started 12 days after the vaccine.   Started with achy, weak legs like I was getting the flu and a sore throat, low grade fever - 99.4.  With fluids and rest, I was better by 5/2. Then on 5/4 , the heavy, weak achy legs returned.  I developed nausea and vomiting, fever as high as 101.2 , chills and on 5/10 I had blisters on my right foot and leg  when I woke up in the morning.
nightmares; Muscle pain; Fall; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (nightmares), PAIN IN EXTREMITY (Muscle pain), FALL (Fall) and FATIGUE (Exhaustion) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Heart failure (patient had three heart strokes in 2019) in 2019. Concurrent medical conditions included Blind (Blind in one eye). Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Blind, GLIPIZIDE, METFORMIN, LOSARTAN, WARFARIN and LEVOTHYROXINE for an unknown indication.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced NIGHTMARE (nightmares), PAIN IN EXTREMITY (Muscle pain), FALL (Fall) and FATIGUE (Exhaustion). On 21-Mar-2021, PAIN IN EXTREMITY (Muscle pain) had resolved. On 22-Mar-2021, NIGHTMARE (nightmares), FALL (Fall) and FATIGUE (Exhaustion) had resolved. Not Provided          Treatment drugs were not provided Patient needs a right knee operation (from before this fall). Patient had three strokes in 2019, had a heart condition. Patient used a walker
Past elbow gets major cramp; Fingers get numb; Very tender at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Past elbow gets major cramp), HYPOAESTHESIA (Fingers get numb) and VACCINATION SITE PAIN (Very tender at site of injection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced MUSCLE SPASMS (Past elbow gets major cramp), HYPOAESTHESIA (Fingers get numb) and VACCINATION SITE PAIN (Very tender at site of injection). At the time of the report, MUSCLE SPASMS (Past elbow gets major cramp), HYPOAESTHESIA (Fingers get numb) and VACCINATION SITE PAIN (Very tender at site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Thingly sensation in the right arm (vaccination in the left arm).; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Thingly sensation in the right arm (vaccination in the left arm).) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Thingly sensation in the right arm (vaccination in the left arm).). At the time of the report, PARAESTHESIA (Thingly sensation in the right arm (vaccination in the left arm).) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported; 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.
This spontaneous case reported by a physician, describes the occurrence of severe diarrhea in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 027A21A) for COVID-19 immunization. No medical history reported. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 16, 2021, patient had severe diarrhea. At the time of the report, severe diarrhea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Patient received Moderna COVID vaccine on 2/10/21 (lot # 015M20A), 3/10/21 (lot # 040A21A), and 1/11/22 (lot # 066H21A). On 1/25/22, patient admitted to our inpatient facility (med/surg unit) with decreased PO intake, hypernatremia, leukocytosis, and COVID19 infection. As of today (1/27/22), patient is still admitted in the med/surg unit and COVID19 infection appears to be largely asymptomatic. Leukocytosis has now resolved, suspect heme-concentrated.  Chest x-ray clear, urinalysis without evidence of infection, blood cultures negative so far.
Joint swelling and pain in fingers and feet since vaccination day. Joint pain ( intermittent) in knees since vaccination day Headache  for five days Nausea for the days
PT recovering from poison ivy. Reported move ? rashes 24 hrs after Help B vax.
Patient received vaccine 10 days after the beyond  use date. Beyond use date was on 11/20/2021. patient has chosen to not re-vaccinate
This spontaneous report as received from a wellness ambassador via company representative refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing details, route, vaccinate site, lot#, expiry date were not reported) for prophylaxis which was reconstituted with sterile diluent(MERCK STERILE DILUENT) (dosing details , lot#, expiry date were not reported). The vaccine was not administered by the reporter.  On an unknown, date the patient experienced a bad case of shingles (herpes zoster). The outcome of herpes zoster was unknown. The reporter did not provide the causality between the event and the suspect therapies. There were no product quality complaints (PQC) involved. Additional information is not expected as the reporter did not wish further contact.
I had Flu-like symptoms for a day or so. Two weeks after the vaccine I had breakthrough bleeding. The bleeding was very heavy and I noticed it when I urinated. I am menopausal I have not had a menstrual period for 12 years so this was very unusual. I have had many tests and a Pelvic exam as well as a D&C. All tests have been negative. I have had these bleeding episodes six more times during the next couple of months since that time. It stopped but I had another on 09/22/2021. I am not sure if it is done happening.
Loss of hair after the vaccine but no doctors picked up on it. Had a healthy full hair so much so that at age 13y hair was donated to cancer patients wig. After vaccine saw loss of hair that even after many years never recovered.
Patient was administered vaccine and had no reaction at time of administration, but upon leaving the office, fainted and hit his head on the waiting room floor. The doctor was summoned and checked him over and took BP. Brought back to exam room by wheelchair, observed, administered ibuprofen for head pain, but recovered fully and allowed to leave the office.
10mins p/vax pt became pale, diaphoretic, limp, place on the examining table unresponsive for few second BP unchanged;no stridor, no wheezing, no resp distress;
This case was reported by a consumer via call center representative and described the occurrence of upper back pain in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (left side beginning at spine in upper back). On 6th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced upper back pain. On an unknown date, the outcome of the upper back pain was not recovered/not resolved. It was unknown if the reporter considered the upper back pain to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The age at vaccination was not reported. The patient had pain on her left side beginning at spine in upper back where she previously had shingles and that stayed continuously. The patient stated that she was hoping that she did not activate a continuing problem for herself by having the shot. The patient wanted to know if others had this problem. She had not informed her physician about the symptoms as she wanted to see if this was a typical reaction before she contact her physician. The patient was informed that the events she had described was not listed as one of the more common side effects, but this was not to say that SHINGRIX was not causing her to experience these symptoms. It just was not observed as one of the common side effects in the clinical trials. The patient would contact her physician to see what she needed.