chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 19-Dec-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office staff). This case is linked to cases 2018SA39350, same reporter. This case involves a 6 months old male patient who received vaccine PENTACEL. The patients past medical history and family history were not provided. Concomitant medications included ROTO-TECH via oral route. On 07-Dec-2018, the patient received a 0.25ml dose of suspect PENTACEL lot C54009AA, expiry date 10-Oct-2019 via intramuscular route in the right arm. It was an actual medication error due to inappropriate reconstitution technique and vaccine underdose. It was reported that PENTACEL vaccine was given to six month olds without it being properly mixed with the diluent. The powder part of the PENTACEL vaccine that were diluted with sterile water. It was unknown whether patient experienced any adverse reaction after the injection. 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 and Module VI of the 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 chills fever and nausa  now have very high bp  almost all the time even though taking meds 3/10
Shingles started 5 days post booster vaccine.  First 2 doses Moderna with no reaction. This was a booster vaccine
Several days after vaccine administration, pt developed red, hot and swollen area. Hurts to raise her arm. Pt given Allegra and Lorabid. On 03/20/2002 pt was given Prevnar by mistake. Manufacturer recommended waiting 6-8 weeks before giving her the pneumonia vaccine. Pt declined to wait and just got it on 03/27/2002.
very severe pain in left arm; sensitive to touch;  inability to use entire arm and high anxiety as I have a history of CVD we called 911; ambulance attendant said he thought it was reaction to vaccination not heart attack as my other signs appeared normal but could not be sure so I was transported to Hospital Emergency after receiving an EKG, hospital staff advised I was okay and clear to leave if I wanted to I took an Aleve when I got home and lorazepam 1 mg from an existing Rx supply I have. I was much better next day. Full recovery in 48 hours.
Arm sore & "queasy" first 1-2 days after vaccines. For last 3 days has had nausea & vomiting (had 2 episodes of emesis on Tuesday & one last night). Has eaten off & on during this time period sometimes no nausea. Has been taking fluids.
Approximately 6 days after vaccination #1, my son developed a lump under his left armpit, same side as his injection.  After receiving his 2nd dose, 21 days later, in the same arm, the condition worsened. It is now larger and painful to the touch. Physician completed exam and determined it to be Lymphadenopathy due to Covid vaccine.
Ongoing Left wrist pain and swelling with axillary lymph node enlargement a couple of days following the vaccine admin. Xarelto 15mg take as directed Xarelto 20mg take as directed
Patient felt dizzy after injection, head hit the plexiglass divider at pharmacy counter.  Pharmacist was able to go out and grab her before she fainted.
intense ear pressure; numbing of left ear and left jaw; headache; Blood pressure has increased; Numbing in right cheek; This is a spontaneous report from a non-contactable consumer. This 47-year-old female consumer (patient) reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0158) via an unspecified route of administration on 15Apr2021 at 10: 45 AM (at 47-year-old) on left arm as dose 1, single for COVID-19 immunization. The medical history of the patient included allergy to amoxicillin & tylenol with codeine. The other medical history was reported as none. The patient did not receive any other vaccine in four weeks and other medications in two weeks. She did not have covid prior to vaccination and was not tested for covid post vaccination. The patient's concomitant medications were not reported. On 15Apr2021 at 12:00PM, one hour after the vaccination, the patient experienced numbing in right cheek. In the evening at 9pm, same day, she had intense ear pressure and numbing of left ear and left jaw. She had massive headache and her blood pressure had increased. The patient visited the emergency room and physician office. She received treatment with high blood pressure medication & anti-inflammatory. The patient had not recovered.  No follow-up attempts were possible. No further information was expected.
Serum sickness developed day after H1N1 mist. Diffuse arthralgics wrists/elbows/carpals, tarsals (MTP's), knees, ankles, diffuse rash - hypopig center with erythema tous rings.
Red, swollen, inflamed arm. Went to ER 2x and received antibiotics.
On Thursday  3/4/21after breakfast,  patient began to vomit and have diarrhea at the same time.
ASTHMA ACTING UP; SEVERE AND EXCESSIVE VOMITING; ACHES; FEELING HOT; PUPILS LOOK LIKE NEEDLES; EYE STRAIN; REALLY SICK; FAINTING; BLACKING OUT; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown Expiry: Unknown) dose was not reported, with frequency 1 total administered on 08-JUN-2021 for prophylactic vaccination. The batch number is not reported and has been requested. Concomitant medications included fluticasone propionate/salmeterol xinafoate (Aadvair) for asthma.  On JUN-2021, the patient experienced fainting which included episodes of blacking out along with aches, feeling hot, pupils look like needles, eye strain, really sick, severe and excessive vomiting not so much nausea but it was reported that patient was puked to the point of having nothing left in his stomach.  On 08-JUN-2021, post 45 minutes of vaccination the patient experienced asthma acting up. It was also reported that patient had been administered with a nebulizer (name unspecified) which did not help hime therefore he gone through the last fourth of a rescue inhaler which he had on his hand during those last 24 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe and excessive vomiting, fainting, blacking out, aches, feeling hot, pupils look like needles, eye strain, asthma acting up, really sick and not so much nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210619325-COVID-19 VACCINE AD26.COV2.S-fainting, blacking out. This event(s) is considered unassessable. The event(s) 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(s).
20 minutes after vaccination, started with localized stabbing pain that continued to spread-from shoulder to elbow. Ice applied and symptoms slowly resolved over few hours.
p/vax pt devel sl soreness @ 12:30;10/10/99 redness in evening & warm;hard lump size of plum;sx peaked @ 4AM 10/11/99;
OFFLABEL USE; Interchange of vaccine products BNT162B2 and J&J Janssen COVID Vaccine; COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 (Lot number: FH8027) at the age of 64 years as dose 2 (booster), single for covid-19 immunisation; covid-19 vaccine janssen (COVID-19 VACCINE JANSSEN), administered in arm left, administration date 06Mar2021 (Lot number: 1805022, Expiration Date: 2021) as dose 1, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "OFFLABEL USE"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products BNT162B2 and J&J Janssen COVID Vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: blood test: liver inflammation.; sars-cov-2 test: covid virus, notes: He was later diagnosed with COVID virus.  No follow-up attempts are possible. No further information is expected.
Rash, swelling, pain in left thigh starting about 24 hours after vaccines. Antibiotic and Orapred started. will be rechecked 48 hrs.
Pt had seizure, stopped breathing following day after receiving vaccinations. 12/11/04 requiring emergency treatment and hospitalization.  4/27/06 Review of 16- page d/c summary indicated gasping & cyanotic at onset of AE. also cardiac arrest, CHF, shock, severe metabolic acidosis, cerebral edema. Reviewed 90-page lab no new medical diagnoses.
Migraine and inability to sleep starteing at about 6:00 am the next day, April 1, and continuing until the submission at 4:00PM. Mild fever as well.  Headaches so bad I can?t focus
11/29/21 at 3:08pm, patient was administered her first dose of Pfizer for 5-11 years of age. Patient is 14 years of age. CDC was contacted about the incorrect dose given. It was stated that patient's between ages 12-17 years, do not to repeat any doses and the second dose be administered as the Pfizer 12+ in the interval of 21 days to complete the primary series.
pt received afluria qiv pfs vaccine. pt passed out about 10 seconds after the shot. pt went ridged, slumped over and had decreased breaths. pt was pale. pt aroused after about 30 to 45 seconds and started speaking about 1 to 2 minutes after passing out. the father held the daughter's jaw line to increase air flow. had pt start talking and got her some orange juice. pt had some shakiness. found out from her mother pt has history of passing out after blood draws. but never from flu vaccines. stayed with pt for another 15 to 20 minutes. pt was able to walk with minimal assistance from her father. she was laughing and talking when she left.
Chronic inflammation in upper left arm.  Bursitis with pain not helped by anti-inflammatory drugs.
Information has been received from a registered nurse concerning her daughter who sometime in 1998 was vaccinated with a dose of RECOMBIVAX HB.  Her daughter hyperventilated after the administration of the vaccine.  She sought unspecified medical attention.  At the time of the report the patient's outcome was unknown.  No product quality complaint was involved.  No further information is available.
body aches, chills and mild abd cramping; was recommended to take otc analgesics of choice. call back as necessary..
Administered expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergo any temperature excursions.  Vaccine expiration date was reported as 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received included reporter details.
Muscle pain, Pain goes from muscle between butt and knee; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain, Pain goes from muscle between butt and knee) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Muscle pain.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain, Pain goes from muscle between butt and knee). At the time of the report, MYALGIA (Muscle pain, Pain goes from muscle between butt and knee) outcome was unknown.            Products known to have been used by the patient, within two weeks prior to the event, included statins.  Treatment information was not provided.
cramps became so severe after being vaccinated with the Pfizer vaccine, that she cannot stretch her calves without cramping and must now begin PT to try to help with symptoms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "AML" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "cramps became so severe after being vaccinated with the Pfizer vaccine, that she cannot stretch her calves without cramping and must now begin PT to try to help with symptoms".  Additional information: Other medications in two weeks: vitamin D3, mag w potassium, Hyland's leg cramp.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dr. came into clinic and received Moderna Bivalent 0.5 ml dose in left deltoid muscle.  He reports that approximately 12 hours later he developed chills and muscle aches.  At approximately 0630 am he developed a severe headache.  He reports by mid-morning her was starting to experience chest pain and contacted his primary care physician who instructed him to go to the hospital ER for evaluation.  He was diagnosed with Myocarditis during his visit at the ER.  He was sent home from ER after spending a few hours there being monitored and assessed.
pt seen 11NOV96;rash abd 1 1/2 wk covering most of body;tx Claritin d/c;tx medrol, Tagamet, Atarax;
A report has been received from a physician concerning a child, subject of unknown gender, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. Th4e patient experienced stinging in nose. The outcome of the event of stinging in nose is unknown. The report was considered to be non-serious.
I started feeling intense chest pain a couple of days after vaccination. I went to the ER for the pain. Later I was referred to a cardiologist where they conducted additional testing. They found inflammation. I  cant do any strenuous activity and they have to do further testing on my heart, which is interfering with my job. I'm still having the chest pain.
Achy; Tiered; Joint Pain; Chills; Fever 103 F; muscle pain; Injection Site was a little Red; Injection Site was a little Sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection Site was a little Red), VACCINATION SITE PAIN (Injection Site was a little Sore), MYALGIA (Achy), FATIGUE (Tiered) and ARTHRALGIA (Joint Pain) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (survived) in April 2020.    On 21-Jan-2021 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection Site was a little Red) and VACCINATION SITE PAIN (Injection Site was a little Sore). On 22-Jan-2021, the patient experienced MYALGIA (Achy), FATIGUE (Tiered), ARTHRALGIA (Joint Pain), CHILLS (Chills), PYREXIA (Fever 103 F) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) on 22-Jan-2021 for Fever, at a dose of 500 milligram three times a day. On 22-Jan-2021, VACCINATION SITE ERYTHEMA (Injection Site was a little Red) and VACCINATION SITE PAIN (Injection Site was a little Sore) had resolved. At the time of the report, MYALGIA (Achy), FATIGUE (Tiered), ARTHRALGIA (Joint Pain), CHILLS (Chills) and MYALGIA (muscle pain) had not resolved and PYREXIA (Fever 103 F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 103 f (High) 103 F and 101.2 f (High) After taking Tylenol went down to 101.2 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
I did not feel the shot going in, so much so that I wished I had looked to see if I was actually vaccinated. About 6 hrs after vaccine, I felt soreness at the injection site, very similar to the flu vaccine. About 12Hours post vaccine, my arm was so sore I could not lift it. That night I took two Tylenol and had to wrap my arm in a heating pad. I woke up around 3am that following morning with a fever of 104 F. I was so dizzy from the high fever. I felt extremely nauseated. My body ached mostly in my legs and lower back. It hurt to sit on the toilet, to put on clothes. My Fevers happened at night time ranging from 102-104F for 4 days. My injection site soreness lasted for 7 days. Body aches lasted around 2-3 days. Dizziness subsided after my fever broke, but was replaced with a severe headache lasting 2 days.
Patient's wife calls the pharmacy stating the patient had a fever and is coughing a lot. She stated he has tried albuterol, spiriva, and breo to stop the cough and nothing has helped.
Fever for 3-4 nights, very high fever, lethargic, turning blueish when upset, lose of consciousness requiring emt sevices and er 3 times, fading, loss of eye contact, loss of speech level, add type behavior, difficulty calming down, obstinate behaviors, holding breath, excema, extreme excema open, allergies,
Paresthesias to bilat hands, respiratory distress, fever, nausea/vomiting/diarrhea, body pain.
Within 8 hours of receiving the vaccine, I started to feel weak and began to develop a fever. By that night I had a 102f fever. My muscles were very achey, and my heart was racing. I was slightly nauseous but still able to eat a little. By 24 hours after the shot my fever was down to 99f.  I started to get diarrhea beginning the second day and has lasted until now the third day after vaccination day.
Moderna vaccine was stored in the refrigerator and administered past the BUD date; Moderna vaccine was stored in the refrigerator and administered past the BUD date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was stored in the refrigerator and administered past the BUD date) and PRODUCT STORAGE ERROR (Moderna vaccine was stored in the refrigerator and administered past the BUD date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was stored in the refrigerator and administered past the BUD date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine was stored in the refrigerator and administered past the BUD date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was stored in the refrigerator and administered past the BUD date) and PRODUCT STORAGE ERROR (Moderna vaccine was stored in the refrigerator and administered past the BUD date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Beyond use date was reported as 01 Nov 2021. CDC expiration date reported as 19 Mar 2022. No treatment medications were reported.
Flu symptoms,  fever, headache, sever leg muscle aches and rash on stomach and at injection site
Patient states that since the HAVRIX shot she has had a nodule come up near the area in which she has noticed it growing in size and causing minimal tenderness.
HEADACHE, INJECTION SITE PAIN, EXTREME FATIGUE, BODY/MUSCLE ACHES, SWEATING/FEVERISH, CHILLS, GENERAL MALAISE
Following vaccine administration, client became pale and when asked if she felt okay, replied "No". Appeared as though she was about to lose consciousness. Assisted to lie down by RN, legs elevated, cool pack placed to posterior neck area. Color better. Answered questions appropriately. Assisted to sip on apple juice. Remained in supine position for approximateley 8 to 10 minutes. Assisted to sit, stand, and transferred to chair. Alert and Oriented x3. Sipping on remainder of apple juice. Observed while sitting in chair for approximately 5 min. Assisted to stand and walk a short distance. Denies dizziness or nausea.
nausea; Vomitting; 101 temperature; Chills; shakes; This is a spontaneous report from a contactable nurse, the patient. A 69-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 18Mar2021 at 11:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patients medical history included common variable immunodeficiency (CVID). The patient was allergic to dairy, sugar, hops, mushrooms, sesame, spinach, turkey, whole wheat and yeast). Concomitant medications included baclofen (MANUFACTURER UNKNOWN) 10 milligram (mg) and D2 ergocalciferol (MANUFACTURER UNKNOWN) 50,000 units. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 20Mar2021 at 05:00, the patient experienced nausea, vomiting, 101 temperature, chills and shakes. No treatment was received for these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of nausea, vomiting, 101 temperature, chills and shakes was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
It began with my legs feeling like lead. They felt half asleep and something wasn?t right. I went to the ER in Friday and after numerous tests and 11 hours they sent me home. By Monday I could not walk at all. I could not lift my legs and I could not get up off the floor. I ended up back at the ER where they admitted me and went on to discover it was Guillain barre syndrome. I then had 5 days of IVIG and was released three days later.