chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first vaccine I had some pain in my arm that would come and go for the four weeks before I had the second shot.  The second shot  (Moderna 025A21A) was given on March 10, 2021. Seven days later I got a pain that went down my left arm into my hand and then a feeling of "pins and needles" in my thumb and pointer.  This too would come and go but unlike the first shot, when I would get relief from taking Advil, now Advil did not have any effect.  Sometimes I would also get a soreness on the side of my hand closer to the pinkie finger.  The discomfort is worse when I am on the computer using the mouse with my right hand.
Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no drug reaction and allergies who on an unspecified day was vaccinated IM with the first 0.5ml dose of GARDASIL (lot number not provided). Concomitant therapy included oral contraceptive. In December 2009, some time after the first dose of GARDASIL, the patient had an abnormal Papanicolaou (pap) smear. The smear revealed a "CIM-3 abnormality with carcinoma in situ." On 12-FEB-2010 the physician performed a LEAP procedure on the patient. On 08-SEP-2010 this patient's follow-up smear revealed that no HPV was present. The physician also mentioned that the patient received a second dose of GARDASIL (lot number not provided) late on 10-NOV-2010. At time of the report the patient was recovered. Upon internal review, a "CIM-3 abnormality with carcinoma in situ". was determined to be an other important medical event. Additional information has been requested.
I had body ache, coughing, SOB, congestive, headache, and running nose. These symptoms lasted for over a month.  I contacted my doctor on Dec 27th. They did a COVID-19 and Flu test. I tested positive for COVID-19 on Dec 30th. I still was having SOB and high blood pressure. I went back to my doctor on Jan 17th. They did blood work and another COVID-19 tests.
Heart Rate was 36; Having Trouble Breathing; Upper back pain; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left (given in the morning) on 21Jul2021 (Lot Number: EW0196) as single dose (at the age of 62-years-old) for COVID-19 immunization. Medical history included ongoing anxiety (she takes Venlafaxine for Anxiety), bronchitis (issues with bronchitis), and hysterectomy. Concomitant medications included venlafaxine hydrochloride taken for anxiety. No Prior Vaccinations (within 4 weeks), no adverse events following prior vaccinations. The patient experienced having trouble breathing and upper back pain on 23Jul2021 (Afternoon on Friday), then heart rate was 36 on 12Aug2021. She had the vaccine probably now over 3 weeks ago. Over the course of the 3 weeks she was having trouble breathing and long story short, she ended up getting a pacemaker. She also saw her Chiropractor, because she figured it was a chiropractic issue at first. The trouble breathing and back pain started within 2 days after her vaccine, which was on 21Jul2021. The pacemaker was placed on 12Aug2021. Treatment: Pacemaker and Ran Tests. She was working for her daughter at a horse show for 1.5 weeks, which is why she didn't go sooner. The events required a visit to Emergency Room. She was transported by Ambulance from the doctors. Pulse rate at that time was 36 and that is when they panicked. On 10Aug2021, she didn't go earlier because she figured it was just her lungs, because it was not that she couldn't breathe, just trouble getting her air. Daughter kept texting her to see how she was, didn't want her to get her vaccine. Figured it was her back. Didn't think it was heart related. The events (Trouble Breathing Pulse Rate and Back Pain) required a visit to Physician Office on 10Aug2021. She didn't realize her pulse was that low, no experience before. The patient was hospitalized for the events from 10Aug2021 to 12Aug2021 (for 2 days). The patient underwent lab tests and procedures which included heart rate: 36 on 12Aug2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovered on 12Aug2021.
In September, 1999, the pt received her first dose of Lymerix. The next day, she experienced flu-like symptoms and fever. No treatment was given. The most recent information, received on 9/25/99, reports that the condition of the pt is recovered.
GARDASIL 0.5ml IM given in LD. Within 2-3 min client became pale then immediately limp, fell to her right, and struck her head on the table on her right, followed by a 5-10 sec seizure as we righted her body to lie her on the floor (head and torso twitching). Within 1 min of twitch ceasing client was layed on the floor and alert. Client then answered appropriately to questions that her step-mother asked her. Ice was applied to quarter size knot on the rt outer forehead x 15 min. Client pale and cool. Client reported at this time that she did not remember hitting her head, but was aware of her head and torso twitching, but could not speak. BP 80/40 with very thready pulse. 10:30 Child sat up and stated that she was lightheaded. BP 70/30 pulse very thready (lying down). 1100 am Child sat up then moved to a chair. C/O lightheadedness and pain where she hit her head. Color - pale. Moved to a cot in the room with HOB elevated. 1115 C/O being cold. Given bottle of cold water. Small individual room heater placed in room. Father present. 1130 Color good, warm/dry, BP 100/60 lying; BP 100/60 after walking around the room. Pulse strong/steady & regular at 806pm. Father left. 1145 Client asking to leave. Ambulated with supervision to step-mother's vehicle. I/S provided to step-mother on signs/symptoms that would require ER care. 11-11-11 3:10 pm At home: Continues to c/o H/A otherwise acting normally as indicated by step-mother per phone.
Large bruise (2" wide, 3"long) became very dark noticed ten (10) hours after vaccine injected. Large red rash on arm noticed eight (8) days later, extending above and below bruise. Not itchy. Arm had some pain at site of vaccination day after vaccination.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing); "Obese" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99 degrees; SARS-CoV-2 test: (27Apr2022) Positive, notes: tested positive on home test; (02May2022) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Inability to walk and lost of feeling throughout body. Was hospitalized for 3 days and given steroids + Physical therapy which helped.
had a temperature excursion and was administered; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number T2S4Z, expiry date 20th November 2022) for prophylaxis.   On 15th September 2021, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: This case was reported by the medical assistant. The age at vaccination was not reported. The reporter reported that Engerix B had a temperature excursion and was administered to a patient.  The vaccine was stored at 8.3C for 1 hour. No additional information was known. No additional adverse event reported. No PQC.
Vomiting, episodic abdominal pain/cramps, no fever, mild diarrhea, hives. Patient was hospitalized 2-3 days later at hospital under MD care. Diagnosed with gastroenteritis, dehydration and OM. 60DAY FOLLOW UP STATES PT HAS RECOVERED.
Patient had vaccine and 15 minutes later at 1445 started experiencing mild hives, discomfort. Patient has history of auto-immune disorder/celiac. Given benadryl 50mg IM on RT side. Patient color has improved; 02 stats improved. Pepcid 20mg. Advised patient to consult provider and front load benadryl prior to next appointment.
Pt developed acute swelling and discoloration of entire portion of both legs. He also had extended crying the entire day.
Soreness, heat, swelling, redness continued to be becoming larger and larger. On 3rd day size was over 3 inch in diameter and on 5th, it passed over elbow. On 7th day, it went down. Feel warmth to touch, blistering round spot appeared below injection site the night she got injected.
Approximately 4 hours within injection,  Pt developed redness and lump at site approximately 2-3 cm in diameter.
Small rash on the arm, just below the injection site, appeared about 10 days after the vaccine.  Faded slowly over several days.
Joint pain in hip and knees, severely limping by July. began using cane to walk in Oct, burning in left hip and itchiness at injection site. Was diagnosed with osteoarthritis.
No adverse event; Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date; Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date), POOR QUALITY PRODUCT ADMINISTERED (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date). On 24-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date), POOR QUALITY PRODUCT ADMINISTERED (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date) and POOR QUALITY PRODUCT ADMINISTERED (Given vaccine which underwent temperture excursion/ Given vaccine which was beyond the 30 day use by date).    Concomitant medication was not reported.  Patient received vaccine which was beyond the 30 day use by date and underwent temperature excursion between 15-Aug-2022 and 17-Aug-2022.   Treatment medication was not reported.
Patient was given the Menactra Vaccine on 11/6/07.  The patient was then given the Menactra vaccine agian on 2/14/08.  The patient did complain of any side effects.
wrong vaccine administered; product confusion; No additional AE reported; This spontaneous report was received from a registered nurse and refers to a 2-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On an unknown date in 2022, the patient was accidentally vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, lot #, expiration date and route of administration were not provided) instead of receiving planned vaccination with either pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (strength, dose, formulation, lot #, expiration date and route of administration were not provided) or pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) pre-filled syringe (strength, dose, lot #, expiration date and route of administration were not provided) (Wrong product administered, Product confusion). No adverse events were reported (No adverse event).
Received Small Pox vaccine as a child.  1st Small Pox vaccine on 9 Apr'08 did not take.  Small Pox re-vaccinated on 21 Apr'08.  Within 5 days, caught very hard cold/flu.  Coincided with Small Pox vaccination site pussing and reacting.  Fever (100.8) and malaise for 4 days.  Cold symptoms very, very strong.
Patient had itching on the Left arm; Patient had rash on the Left arm; Rash on neck, back, and legs; the patient had itching neck, back, and legs; cold; fever; patient is so upset; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (the patient had itching neck, back, and legs), NASOPHARYNGITIS (cold), FEELING ABNORMAL (patient is so upset), INJECTION SITE PRURITUS (Patient had itching on the Left arm) and VACCINATION SITE RASH (Patient had rash on the Left arm) in a 31-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer Vaccine; for COVID-19 prophylaxis: Moderna Covid-19 vaccine (2 doses). Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine and Pfizer Vaccine.    On 13-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PYREXIA (fever). On 15-Oct-2023, the patient experienced PRURITUS (the patient had itching neck, back, and legs), NASOPHARYNGITIS (cold), INJECTION SITE PRURITUS (Patient had itching on the Left arm), VACCINATION SITE RASH (Patient had rash on the Left arm) and RASH (Rash on neck, back, and legs). In October 2023, the patient experienced FEELING ABNORMAL (patient is so upset). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (the patient had itching neck, back, and legs), NASOPHARYNGITIS (cold), INJECTION SITE PRURITUS (Patient had itching on the Left arm), VACCINATION SITE RASH (Patient had rash on the Left arm) and RASH (Rash on neck, back, and legs) had not resolved, FEELING ABNORMAL (patient is so upset) outcome was unknown and PYREXIA (fever) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient stated that, still battling the rash and could not sleep on her back. She felt a little cold, tried to place a blanket on her but it makes her itch, so she had to remove the blanket. She can could not wear long sleeve because of the rash and itching. She has to go to school and all that, but she couldn't even do anything. Her situation was horrible.  The cream has not improved her situation. Urgent care said it was a side effect of the vaccine and it may take a few weeks for it to go away. She was also taking Benadryl, but it was not helping. She bought Allegra.   Reporter did not allow further contact
Red raised hives arms, abdomen, legs, itchy hands with rash, No SOB - Rx: OTC BENADRYL. 9/22/16- 36 hour later, awoke with hives, swelling - to ER. IV SOLU MEDROL with Scrip for Po. FYI  Pt walked thru wood before injection. 9/22 12pm Woke the AM with hives face, hand swelling, feeling of "fire ants crawling on him" and short of breath. Went to hospital as directed - tx with IV steroids. Per patient - ER doctor said, this reaction to vaccine rare but pt. states only potential allergen. Advised to f/u with Dr and now to list vaccine as his allergy.
I was asked to sit after shot for 30 minutes vs 15 minutes (shot was at 9:33 A.M., because I have a sensitivity to sugar alcohols. At 25 minutes, my heart rate increased in the chair,, the tip of my tongue began to tingle. When I stood up to alert a staff member, my head began to 'swim', like it was full of water. My speech became slow and I couldn't quite find the words to speak quickly to answer the staff's questions. My walking was slow and wobbly. Staff took me to a secluded room, where vitals were taken four different times throughout my seclusion. My b/p was high at first, I was dizzy and not thinking clearly. It took until 10:55 A.M. before my tongue tip no longer tingled, but became numbish, and my head became clearer. I was able to stand on my own, and then walk out to my car.
I got an outbreak of guttate cellulitis that was all over my body.  It continued on about 6 months.  I have never had it this bad.  It is starting to finally clear up.
Spoke with patient at 3:59PM on 4/13/2021 when she reported that on 4/7 at 3am she began experiencing severe body aches, chilling and headaches.  She also experienced severe dizziness and light headedness to the extent she felt she could not drive for 2 days.  Dizziness is about "60% improved" per patient although it does return if she sits up too quickly.  She reports leg cramps and the legs feeling "heavy" like "when you have the flu" like "when you have been running for a week."  She has taken acetaminophen with minimal improvement.  Recommended she speak with her health care provider as soon as possible or the ED if symptoms worsen.  She reports she plans to see her primary care provider tomorrow (4/14/2021).
Information has been received from a nurse concerning a patient who was vaccinated with VARIVAX (Oka/Merck) (therapy started date, route, site unknown) developed breakthrough chicken pox after the second dose. Patient's medical history and drug reactions/allergies were unspecified by reporter. The reporting nurse noted the patient's case of chicken pox was mild with less than 50 lesions and sought medical attention. On an unspecified date, patient had recovered. This is one of several reports received from the same source. Additional information has been requested.
Fever, muscle aches, fatigue, vomiting, diarrhea, biatrial enlargement, high blood pressure
hypokalemia, myalgia, severe lightheadedness/dizziness, nausea and vomiting
Within 5 mins ringing ears which has continued to present. Numbness on left side of face and trouble swallowing.  Face and swallowing appeared within 4 hours of shot.   Took Alleve, Tylenol, and Benadryl to reduce swelling which helped with swallowing but left  lower face along jawline is still numb.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOACUSIS, OTITIS MEDIA (serous otitis media), FACIAL PARESIS, LACRIMATION INCREASED and HYPOAESTHESIA ORAL in a 50-year-old female patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Apr-2021, the patient received first dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (MODERNA COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced HYPOACUSIS. On 23-Apr-2021, the patient experienced OTITIS MEDIA (serous otitis media). On 29-Apr-2021, the patient experienced FACIAL PARESIS, LACRIMATION INCREASED and HYPOAESTHESIA ORAL. On 29-Apr-2021, OTITIS MEDIA had resolved. At the time of the report, HYPOACUSIS, FACIAL PARESIS. LACRIMATION INCREASED and HYPOAESTHESIA ORAL had resolved. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD21-084619 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Event Outcome Updated: "No Symptoms at present."; Sender's Comments: MOD21-084619.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 13-MAY-2014, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at the department of health as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster.  On or about 10-JUN-2016, the patient was treated by a physician (site not specified) for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving 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, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown.  Additional information has been requested.
pretty bad side effects pretty severe side effects third  dose also did  second dose last year; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (pretty bad side effects pretty severe side effects third  dose also did  second dose last year) 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.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (pretty bad side effects pretty severe side effects third  dose also did  second dose last year). At the time of the report, VACCINATION COMPLICATION (pretty bad side effects pretty severe side effects third  dose also did  second dose last year) outcome was unknown.            No concomitant drug were reported.  Patient had pretty severe side effects that took place this week after received their third dose also did  second dose last year and  had pretty bad side effects back then as well.   No treatment drug were reported.   This case was linked to MOD-2022-459022 (Patient Link).
This spontaneous report was received from an office manager refers to a patient of unknown age. On 16-AUG-2013, the patient was inadvertently vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) subcutaneously instead of VARIVAX (Merck) and a dose of M-M-R II (dose, route and lot # not reported). No adverse effects were reported. Additional information has been requested.