chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme pain in injection arm; Not able to function; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the arm on 05Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included sulfonamide allergy (allergic to suplha-based medication). The patient received unspecified medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021, the patient experienced extreme pain in injection arm lasted 48 hours. Not able to function. Pain began within one hour of injection. After 48 hours, pain was moderate for additional 24-36 hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with Tylenol, heat packs and cold packs. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events extreme pain in injection arm and not able to function were recovered on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Patient complained of chills, body aches & weakness.  Temperature obtained 99.0.  No other symptoms.
Breakthrough case admission after 2 vaccines  moderna 2/13/21 lot# 031M2-0A;   Moderna 3/3/21 lot# 040A21A
AFTERNOON AND EVENING HAD SORE ARM AND BODY ACHES. AT 2AM WAS WOKE UP WITH HEART RACING AND NAUSEA AND ACHES. TOOK ADVIL AND WENT BACK TO SLEEP. AT NOON ON SATURDAY HAD PAIN AROUND TORSO. MONDAY MORNING ONLY HAS REDNESS AROUND INJECTION SITE.
Patient had flu vaccine 2 days ago and developed swelling to arm, redness, pruritic pain. Vaccine was administered at pharmacy.
In addition to the muscle ache, headache & fatigue I had extreme chills with shakes and fever of 37.7c. Fever didn't respond to Tylenol but it did to Advil. As morning came fever has returned and has responded to Tylenol so far.
Night of vaccination: Extreme pain and stiffness in left arm. Unable to move fingers on left hand. Morning after vaccination: Unable to stand without feeling faint. Got sent home from work because I felt like I was going to pass out. Soreness in right chest, just below collarbone. Day three: sore spot is swollen and hurting worse.
Pt. notified of adverse reactions:  Local swelling, tenderness, etc.  Pt. instructed to call the clinic of any other s/s or concerns.  Pt. states no s/s at this time.
Information has been received from a physician concerning a pediatric male who was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast). Subsequently the pt required speech therapy. Unspecified medical attention was sought. There was no product quality complaint involved. The event which required speech therapy was considered to be an other important medical event (OMIC). No further information is available.
T78.3XXA ANGIOEDEMA, INIT 4/12/2023 FEVER OF UNKNOWN ORIGIN T78.3XXD ANGIOEDEMA, SUBSEQ 4/25/2023 FEVER OF UNKNOWN ORIGIN T78.40XA ALLERGIC REACTION, INIT 3/30/2023 FEVER OF UNKNOWN ORIGIN T78.40XS ALLERGIC REACTION, SEQUELA 4/6/2023 FEVER OF UNKNOWN ORIGIN
Dizziness, fatigue, muscle aches, joint aches, headaches, mild nausea
No additional AE; Patient that was administered an expired dose of MMR II on 09JUL2022; This spontaneous report was received from a pharmacy intern and refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 09-JUL-2022, the patient was administered an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), subcutaneous injection, lot # T020655, expiration date: 16-JUN-2022, administered for prophylaxis (strength, dose, and route of administration were not provided) (expired product administered). No additional adverse events (no adverse event).
I received the Covid 19 vaccine at 12:30PM on Wednesday, 12/23/2020. On 12/24/2020, mid-day, I developed the following S/S (which were similar to a Lamictal rash):  Fine raised red rash over my body, but significantly heavier to face, neck and lower legs; throat swelling with a high pitched cough (with no difficulty breathing) productive with clear thin secretions; diarrhea;  I took 6 benadryl every 4-6 hours, Pepcid twice daily, and had an epi pen available (but did not need it). The cough and rash resolved by late Sunday evening.  I did not report to ED because I felt the symptoms were manageable at home.
Approximately 30 seconds after the injection (which was painless), I suddenly developed tachycardia and felt like my heart was pounding out of my chest. My entire body was extreme tingling and I could not feel my hands or feet.  I also got a sudden strong metallic taste in my mouth. I thought I was about to fall down, but right before I was going to ask for help, the symptoms stopped as suddenly as they came on.  I probably should have said something then, but I felt fine so I walked back to my unit. About 20 minutes after my injection, I then developed an intense hot flash and soaked my clothes with sweat.  I sat down with cool rags on my head and this subsided after about 10 minutes. I have felt fine ever since, other than a little bit of a sore arm  and mild headache (expected).  I?m not sure if my tingling, heart palpitations, and hot flashes with sweating are expected, but I thought I should report it just in case it would be helpful for the manufacturer to know.
Dizziness & Fever Narrative: dose 1-1000 12/29 dry cough, extremely achy joint pain, fever <100 degrees Farenheit, tachycardia 120-130, headache, dizziness, and fatigue. 12/30 symptoms subsided approximately 1200 12/30 dose 2-Fever 101.5, dizziness, mental fog;resolved 1/26
Patient presented to Urgent Care and then was sent to the ED for evaluation.  Found to have pericarditis on EKG.  Labs including troponin reassuring.   Patient discharged home with referral to Cardiology for outpatient follow up.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored PROQUAD (recombinant human albumin) lot # M015698, expiration date 26-SEP-2017 and lot # L051102, expiration date 17-JUN-2017 (dose, route of administration were not reported not reported) for prophylaxis. No adverse effects were reported. This is one of the two reports received from the same reporter. Follow up information was received on 07-DEC-2016. All telephone attempts to obtain follow up have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA008848: MERCK 1610USA009745:Mfr number.
Arm developed bright red rectangular area around injection site. Sore for a few days. Extremely hot to the touch and swollen. Seemed to improve after 5 days with less swelling and pain. At day 8, redness increased again, hard lump in arm with itching.
Outside 42 day period; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside 42 day period) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside 42 day period). On 07-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Outside 42 day period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
pt recv vax 7MAY 330PM flushing, severe migraines, h/a-light sensitivity, severe eye head pain, projectile vomiting came on from about 930-11PM;
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 79 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not having any illness at the time of vaccination. patient had no history of similar events, had no adverse event after any previous vaccination(s). The patient had no history of allergy to food, drug, or vaccine, had no pre-existing acute illness 30 days prior to vaccination, had no history of hospitalization in last 30 days. The patient was not having any family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant nor breastfeeding at the time of vaccination. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered 1 in total, to the right on 11-AUG-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered 1 in total to the left on 16-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-DEC-2021, the patient experienced expired vaccine administered (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382.
felt a little off for 2 days; felt like she was getting the flu; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling abnormal and influenza-like symptoms. On an unknown date, the outcome of the feeling abnormal and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the feeling abnormal and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and  experienced getting the flu and felt a little off which was resolved in 2 days. The reporter did not consented to folow up. No further information was available. This case was linked with case US2020AMR229116 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR229116:same reporter
This spontaneous report was received from a healthcare worker referring to a 9 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 27-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Was sitting on couch, and became nauseous around 4:00 pm when significant other was making making. Ate food and nauseous feeling got more overwhelming. About 5 pm I vomited up all my food. I also started having very bad diarrhea. I puked again about 7 pm after eating a few crackers and drinking water. Then puked four more times between 8pm and 11pm with absolutely nothing in my stomach. I continued having bad diarrhea during this same time. I also got cold chills during this time too. I was intensely nauseous and couldn?t keep my eyes open. I went to the Emergency room around 11pm and they gave me an IV with Saline and nauseous medicine. I went home around 1 am. On Sunday I proceeded to be slightly nauseous and have had a constant headache from Sunday and still have it today on Tuesday. But I  am just starting to more solid foods.  Had diarrhea until Monday afternoon. And haven?t pooped since.
felt ill; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter reported that his friend mentioned that 4 to 5 of his friends felt ill for a couple of days after receiving the Shingrix vaccine. The reporter had very limited information to provide about the event. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020200802:same reporter
The patient received the first dose on 5/17 and on 6/2 had a severe headache and vomiting. The vomiting has since subsided but the patient has had a mild headache ever since
Pain at injection site - pain upon touch for 48 hours post vaccination Muscle aches - started 8 hours post vaccination and lasted for 48 hours Fever/chills - started 12 hours post vaccination, peaked at 103 degrees 24 hours post vaccination, continued as a mild fever until 48 hours post vaccination Fatigue - felt fatigued morning after vaccination and continued until 48 hours post vaccination Menstrual cycle - Experience period starting 48 hours post vaccination, slightly earlier than normally expected.  NO MEDICAL TREATMENT NEEDED
pt recvd vax & exp dose 2 exp sore throat & fever which subsided;
Afternoon of shot pt became sick @ stomach & didn't eat; vomited x 6; ran high fever 103 w/APAP began jerking of body; Mom gave sponge bath; Seen in ER for diarrhea, vomiting & dehydration; Had rash on both hands; running nose;
No adverse effects were reported; Inadvertently administered a dose of MMR II via intramuscular route rather than the recommended subcutaneous route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergy/ drug reaction and concomitant medications were not reported. On 19-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R031629, route: intramuscular (strength, formulation, dose/ frequency was unknown) for prophylaxis. The patient inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) via the intramuscular route rather than the recommended subcutaneous route (incorrect route of product administration). On an unknown date, the patient experienced no adverse event. The outcome of incorrect route of product administration and no adverse event was unknown. The reporter considered incorrect route of product administration and no adverse event to be not assessed to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).
Body pains; Pain at the injection site; 99.9 degrees fever; Fatigue; This is a spontaneous report from a contactable consumer via Pfizer sales/company representative. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 28Mar2021 at 09:00 (at the age of 42-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to food, medications, or other products. Concomitant medication included levothyroxine 75 mcg (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. 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 did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Mar2021 at 22:00, the patient experienced body pains, pain at injection site, 99.9 degrees fever and fatigue. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events body pains, pain at injection site, 99.9 degrees fever and fatigue. The clinical outcomes of the events general body pain, vaccination site pain, fever and fatigue were recovering at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
SICK; STOMACH PAIN; CHILLS; MUSCLE SORENESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 sick, stomach pain, chills, and muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, sick, stomach pain and muscle soreness was not reported. This report was non-serious. This case, involving the same patient is linked to 20211266278.
11/25/2009 Onset L side facial numbness. Taken to Emergency Rm. 12/3/09 ER records received for date 11/25/09. DX: left facial numbness and weakness/asymmetry. Presenting SX: pt/ c/o left facial numbness started this AM. Assessment: WNL. Desired to admit pt for possible TIA but Pt declined to be admitted and signed out AMA.
Arm became swollen and went to the shoulder blade few days after vaccine.  Seen in the ER 10/21 when he started to develop low back pain to the point he could barely walk.
chills, headache, glass feeling under eye, yellow tongue, rash on thigh, nausea, fatigue
Immediate taste in mouth, 10 min later lightheaded/felt rush through entire body, tingling upper arms which persists still today, tingling thighs started the second day and continues today, headache in morning of day 2, fatigue started day 2 and continues today, brain fog started day 2 and continues today
persistent and severe vesicular rash, which was diagnosed as herpes zoster and neuralgia; persistent and severe vesicular rash, which was diagnosed as herpes zoster and neuralgia; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or about 12-JUL-2007, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later on 13-JAN-2014, the patient was treated in a Medical Group, for persistent and severe vesicular rash, which was diagnosed as herpes zoster and neuralgia. The patient was prescribed valacyclovir(VALTREX) and Hydrocodone for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
On day 11 following vaccine, her site became swollen and red. Ice was applied per mom and Tylenol given as needed. Saw MD on 12/21/2001 for pain medication.
Information has been received from a physician concerning a 19 year old female who on 10-JUN-1991 (also reported on 10-JUN-1997) and 03-DEC-1997 was vaccinated with the first and second doses of MMR II (LOT# not reported), respectively. On 24-NOV-2009 the patient experienced onset of mumps. Mumps diagnosis reported as 10-NOV-2009. The patient also experienced headache, fever of 102F and diarrhea twice a day. On 10-NOV-2009, the patient had blood work was done that revealed IgM was 1:10:10, IgG was 0.72 and serum amylase was 204. The patient's outcome was unknown. Follow-up information has been received from a physician concerning the 19 year old female patient who on 02-DEC-2009 had blood work done that revealed IgM was 0.34, IgG was 5.69 and serum amylase was 66. On 12-JAN-2010, blood work was done that revealed IgM was <1:10, IgG was 4.91 and serum amylase was 172; and on 22-JAN-2010, blood work was done that revealed IgM was <1:10, IgG was 6.45 and serum amylase was 245. At the time of the report, the patient's status was unknown. Follow-up information has been received from a physician concerning the 19 year old female patient who on 01-DEC-2009 (previously reported as 24-NOV-2009) experienced onset of symptoms. On 02-DEC-2009 (previously reported as 10-NOV-2009), the patient was diagnosed with mumps. The patient was afebrile and had right parotitis. On 11-JAN-2010 the patient experienced onset of symptoms. On 12-JAN-2010, the patient was diagnosed with mumps. The patient was afebrile, had right parotitis and history mumps exposure in school. On 20-JAN-2010 the patient experienced onset of symptoms. On 22-JAN-2010, the patient was diagnosed with mumps. The patient was swelling under right ear and had right parotitis. At the time of report, the patient's status was unknown. No further information is available.
Low grade fever 99.0-100.8 from 2/12 pm to 2/14 pm; Arm soreness from from 2/12 pm to 2/14 pm; Tiredness from 2/12 pm to 2/14 pm; Chills on 2/13 from 3:30pm-5:00 pm; Cold and clammy episode on 2/15 at around 12 pm... called 911, but symptoms subsided by the time they got to me and my vitals were within normal parameters.
Moderna COVID-19 Vaccine EUA The child came with her mother to get vaccination. There is no adverse event reported.  Moderna vaccine was administered to her when she does not fall within the age group for EUA. It completely escaped my attention and I had a recollection yesterday. The parent telephone number provided was called but no one picked however a voicemail message was left for her to call the pharmacy at her earliest convenience.
Fever symptom and febrile seizure. Ambulance ER visit, oxygen, seizure meds,Tylenol and Motrin administered. No virus or bacterial infection found.