chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 24 hours of the 2nd shot I had a fever that lasted 9 days of 103°, severe joint pain that lasted 17 days, I have had a constant headache behind and above my eyes that has not gone away since getting the second vaccine shot, tightness of the chest that comes and goes, I have had blurred vision especially in low light making it really hard to see, eyes have had a really hard time focusing in low light situations and I can no longer drive at night without lights blinding me, making lights look like bright stars. I am tired all the time and have no energy since getting the second vaccine shot.
Case number PHEH2014US003965 is an initial spontaneous report received from a pharmacist on 24 FEB 2014 with a follow up report received from the pharmacist on 01 APR 2014. This report refers to a 16 year old male patient. It was reported that his previous vaccinations (unspecified) were well tolerated. On 31 DEC 2013 at 06:40 AM, he was accidentally vaccinated , for the first time, with FLUCELVAX 2013/2014 (batch number: 006001, expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly into left deltoid. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).  Follow up report received from the pharmacist on 01 APR 2014: Updated vaccination history (previous vaccine well tolerated), vaccine batch number and vaccination site (into left deltoid).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 01 APR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Patient was given a dose of Pfizer BioNTech that was past its beyond use date. No adverse reactions noted.
Fatigue/exhaustion; felt like flu coming on.  Onset was 3 full days after receiving booster  Symptoms lasted 24 hours
Patient presented at vaccination table after having documents and appointment reviewed by non-clinical staff, and identity was confirmed by Nurse Vaccinator using two unique identifiers (including DOB). Nurse vaccinator reviewed patient's responses to screening form completed in PrepMod and screened patient to confirm she was feeling well, had no history of anaphylaxis, does not carry an epi-pen for allergies, and had not received COVID vaccine previously. Nurse vaccinator educated patient on possible side effects of Moderna product. Patient indicated she wished to be immunized, received Moderna vaccine, and proceeded to observation area where she waited for fifteen minutes before departing from clinic without reporting any adverse event. Patient then presented with parent on April 20, 2021 for second dose.  Nurse vaccinator for second dose explained that patient was under the age of 18 (DOB 02/01/2005) and was unable to be vaccinated.  The parent asked to speak to the clinical lead in COVID-19 vaccination clinic.  The clinical lead contacted the Director of Nursing who was onsite, to speak with the patient and the parent.  The DON spoke with the parent and explained the error that occurred on March 23, 2021 and that the current RN vaccinator couldn?t vaccinate the patient without written consent from the parent.  The parent requested a consent form, the DON reviewed the consent form with both the patient and parent.  Parent signed the consent form and patient was vaccinated.
pt states that about 5 minutes after receiving injection he got into his car and felt an intense knife-stabbing pain at L2 in his spine at the waist area. L2 was a site of a break 25 years ago. Pain lasted about 20 minutes and was immediately accompanied by an adrenaline-like surge and racing heart which subsided quickly. Pt states he felt fear and as if he was going to die, although he suggested it was a sense of panic that probably made him feel that way and it subsided as he began to relax.
Localized swelling at injection site (LVL) left vastus lateralis. Abx given for cellulitis
Patient was given 2nd Fluzone HD dose.  First dose was given on 9/20/2023.
On July 10, 2022 in the middle of the night I woke up and felt congested with runny nose and it was hard to breathe. I went back to sleep. The next morning I had sore throat and headache as well. I also experienced foggy brain. I used Sudafed and drank Gatorade and got back in bed. The following day I used Nyquil and Dayquil to help with symptoms. I was able to work from home but I had super low energy. The major congestion subsided on day 4. I had the sore throat, headache and runny nose for about 7 days. I tested positive again on July 16th. I still had fatigue, sore throat and  headache. I tested negative on July 20th. I felt good enough to ride my bike. As of today I still have a little cold in my chest. I just don't feel 100% yet.
Day after vaccine given left deltoid size of goose egg.  The following day spread out warm and red.
Swollen, painful lymph nodes under arm on injection side.  Tenderness began a few hours after injection.  Large swelling 2 days after. Injection.   Hot, blotchy rash and swelling  (approx 2.5 inch c 3.5 inch) on the injection arm (a couple of inches below the injection site) began 2 days after injection.
Joints felt sore and stiff, skin felt sensitive, almost like pins and needles- particularly along my lower back.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2006, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sudden severe stomach cramping accompanied by bleeding (not on menstrual cycle) bleeding was extremely heavy , bleeding lasted about 12-14 hours  Severe stomach cramping - nausea - and vomiting are continuing  Fatigue
The tech thought the pt got Johnson and Johnson as his primary dose.  The tech told the pt we had Moderna for the booster.  At counseling the pharmacist confirmed with pt that he was expecting the Moderna booster.  After the half dose was given to the pt , the pt said he wanted the Johnson and Johnson and he never received the first dose.  We verified with Moderna ok to give him the other half dose to get him to a full primary dose.  No adverse reactions were reported by patient.  The reason this report was made because pt wanted J&J but got Moderna instead.  Pt wanted J&J becasue he only wanted one dose since he is a truck driver.  After speaking with the pt he wasn't overly upset and we explained he will need a second dose in 28 days.
CLIENT BECAME UNSTEADY ON FEET WHILE CHECKING OUT. WAS ESCORTED BACK TO CLINIC RM. BP 121/78 @ 4:17PM. CLIENT STATED SHE FELT OCCULAR PRESSURE BILATERALLY WHICH EVOLVED INTO OCCIPITAL PAIN IMMEDIATELY FOLLOWING ADMINISTRATION OF MENTACTRA 0.5CC IM L DELTOID. CLIENT DEMONSTRATED FACIAL FLUSHING.  911 WAS CALLED.  CLIENT DECLINED TRANSPORT AND LEFT AMBULATORY WITH EMTs.
palpitations & lightheadedness (started 2 days after vaccine, lasted for approximately 2 weeks);  tinnitus, neck pain, and headache (started a few days after vaccine, still occurring at present)
This case was reported by a healthcare professional and described the occurrence of pimply bumps in a 23-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), MMR II (non-gsk) and RECOMBIVAX.  On 19 April 2010 the subject received 1st dose of BOOSTRIX (unknown, right arm), 3rd dose of MMR II (Non-GSK) (unknown, right arm), 1st dose of RECOMBIVAX (unknown, right arm).  On 19 April 2010, less than one day after vaccination with BOOSTRIX, MMR II (Non-GSK) and RECOMBIVAX, the subject experienced "raised pimple like bumps on arm and shoulder" and "warmth in area".  The subject had raised red pimples and sensation of warmth after receiving MMR II, BOOSTRIX and RECOMBIVAX in his right arm on 19 April 2010.  On 23 April 2010 the subject sought medical care and was treated with Benadryl.  On 28 April 2010 the subject returned to the medical office and he no longer had the symptoms.  The subject was treated with TYLENOL.  On 28 April 2010, the pimply bumps and feeling of warmth were resolved.  The healthcare professional considered the events were probably related to vaccination with BOOSTRIX, MMR II (Non-GSK) and RECOMBIVAX.
if a dose of expired TYPHIM Vi was administered would it still count as a valid dose(with no reported adverse event); Initial information received on 06-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional via call center.  This case involves a 73 years old female patient to whom a dose of expired typhim vi was administered would it still count as a valid dose(with no reported adverse event) while receiving typhoid vi polysaccharide vaccine .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included meningococcal vaccine a/c/y/w conj (tet tox) (Menquadfi) for Prophylactic vaccination.  On 22-Feb-2022, the patient received a 0.5 ml dose of suspect typhoid vi polysaccharide vaccine (unknown formulation and strength) (batch lot T1A671M,Expiry date : 17-feb-2022)via intramuscular route in the right deltoid for immunization.  On 22-FEB-2022 (latency :same day)the patient developed a non-serious event of expired typhim vi was administered would it still count as a valid dose(with no reported adverse event) (expired product administered) following the administration of typhoid vi polysaccharide vaccine.  Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the event .  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.; Sender's Comments:  related case- 01051939:
This spontaneous report as received from the mother of the patient referring male patient of unknown age (also reported as her son). No medical history and concurrent conditions were reported. On an unknown date in October 1999 the patient's mother was vaccinated with a dose of VARIVAX injection (lot number and expiry date unknown) (dosing regimen and frequency unknown) (foetal exposure during pregnancy). It was reported that the mother was not taking any medications concomitantly. On an unknown date the patient experienced different problems (adverse event) and was diagnosed with general rheumatoid arthritis (medically significant) and seizure disorder (medically significant). It was also reported that it could not be confirmed if the patient (the son) received the vaccine. The outcome of the events was unknown. The relatedness of the events to the therapy with VARIVAX was unknown. There was no product quality complaint reported. Upon internal review seizure and rheumatoid arthritis were determined to be medically significant. This case is related to case number 1610USA004331 via mother child link. Additional information has been requested.
Initially chest pain with palpitations which were not reported, hoping they would pass. Now presents with Head ache, slight photophobia, malaise, nausea with vomiting and chunky diarrhea, Given Meclazine, rest, FF in sips and chips
soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness of arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol, LEVOTHYROXINE for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness of arm). At the time of the report, PAIN IN EXTREMITY (soreness of arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Treatment products included Prednisone 20mg, Azithromycin 500mg, Tylenol occasionally.   This case was linked to US-MODERNATX, INC.-MOD-2021-056276 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-056276:
Delayed injection site reaction.  Red, raised, warm area around just below injection site.  Mildly tender to touch, itchy.  Approximately 2 x 3 inches.
04/07/03 Patient stated while at home she had mild chest Pain x 1 occurrence lasting 2 1/2 hrs, nonradiating. 04/08/03@ 2:30 pm pt. notified RN of right arm itching below vaccine site.  Nurse noted multiple satelite lesions around Small Pox vaccine site(Right upper arm) and small multiple lesions on left upper arm, back and shoulders. The lesions were clear fluid filled vesicles.  Patient Afebrile, BP/WNL, Denied pain. Dr. was contacted and evaulated pt. at Health Department. Determined pt. needed cardiac evaluation, and was admitted to Hospital for EKG, ECHO and Cardiac Enzymes on 04/08/03. Universal Precautions were initated and pt. placed in an isolation room. All cardiac work up was negative. Pt. discharged 04/09/03. Cardiologist, Dr. cleared pt. for discharge/Reccommended a Cardiolyte Stress Test in 3 weeks.
mother reported that child had fever of 107.F w/i 12 hrs after dtp/opv.  given tylenol then transferred to er. fever dropped to 104 and child was sent home.
I began feeling very sick, as if I was coming down with the flu at appx. 10:15 AM. I finished my appointment, went across the street to the grocery store.  I was lightheaded and unbalanced. I drove home but have no memory of the trip after leaving the store. At home I became very sick with flu-like symptoms and was unable to maintain balance. I tried to call the doctor but could not talk and was having trouble talking and breathing. The receptionist directed me to call 911. I lost my ability to stand out on the porch and lay down. The Paramedic/EMT's found normal O2, but too little CO2, indicating panic, normal EKG, but elevated BP of 176/110.
Redness at injection site; redness and swelling to ipsilateral shoulder. Next day felt warm, induration 12" X 12 ".
No additional AE/PQC; Inbound call from a medical assistant who reported that improperly stored vaccines were administered. The caller was not sure which ones were administered.  MA to declined to report the AE at this time.  Limited information provided. No additional AE; This spontaneous report was received from the medical assistant and refers to a patient of an unknown age or gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 04-APR-2023, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 milliliter, lot #W010661, expiration date: 19-OCT-2024 (strength, route of administration were not provided) as prophylaxis following a temperature excursion of -40 degree Fahrenheit for 8 hours and 25 minutes, there was mentioned that not previous temperature excursions occurred. No additional adverse event was reported.  This is one from several case from the same reporter. ; Sender's Comments:  US-009507513-2305USA000730:02380645 US-009507513-2305USA008830:
COVID-19; I got the moderna vaccine April (two shots spaced apart by three weeks); Nasal congestion; Loss of taste; Loss of smell; runny nose; ache/ muscle ache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Jul-2021. The most recent information was received on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), RHINORRHOEA (runny nose) and MYALGIA (ache/ muscle ache). At the time of the report, COVID-19 (COVID-19), NASAL CONGESTION (Nasal congestion), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell), RHINORRHOEA (runny nose) and MYALGIA (ache/ muscle ache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I got the moderna vaccine April (two shots spaced apart by three weeks)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jul-2021, SARS-CoV-2 test: positive (Positive) positive (source of sample is nose).         No concomitant medications were provided. No treatment medication information was provided. The patient confirmed having COVID-19 after receiving MODERNA vaccine three months earlier.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Significant Follow up appended : laboratory data added, new events of muscle aches, nasal congestion/runny nose, loss of taste loss of smell were added.
Mom reports that at approx 4pm on 9/1/06 patient's eyes rolled up in his head, he fell off of his chair and was unconscious for a short time.  She observed him for awhile, but he was "not himself" Pt taken to ER was observed and sent home.  He continued to be irritable and cried easily, would not get dressed. Mom called this am saying pt was still not acting quite right.  We have scheduled pt for eval by neurology on 9/8/06
Onset of headache, full body muscle aches from head to toes and fingers, shaking chills, extreme exhaustion These all lasted about 9 hours.  Took two Tylenol PO.  Took a hot bath.
started 1 hr after shot she started to feel nauseous then felt better after a little while. then we were having lunch at 1:30 and she started to vomit.
fever 102F Chills Dizziness, Staginess. Couldn't stand without holding anything. tiredness.
tingling in left hand / tingling of right hand, both feet; tightness in left forearm and bicep; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: EL0140, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 25Feb2021 15:30 (at the age of 64-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included granuloma annulare and hypothyroidism both from an unknown date; breast cancer from 1991 and unknown if ongoing. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN), levothyroxine sodium (SYNTHROID), macrogol 3350 (MIRALAX), colecalciferol (VIT D3) and more unspecified medications all taken for an unspecified indication, start and stop date were not reported.  The patient has known allergies: LEVAQUIN (reaction not allergic). The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 27Feb2021 22:00, the patient experienced tingling in left hand / tingling of right hand, both feet and tightness in left forearm and bicep. No treatment was received for the events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information expected.
Patient fell at home and present to ED department with L hip pain. Patient admitted with acute L femoral neck fracture. Patient swabbed prior to surgery and results came back COVID +
Localized swelling and pain at injection site lasting 48 hours Vomiting and diarrhea  beginning at 2am on March 30th Fever, chills, intense muscular pain and full body tension, headache continued for several hours Took Ibuprofen at 3am and slept,  woke with nasuea that continued for 12 hours, no further diarrhea or vomiting  Muscular pain gradually subsided from an 8 in intensity to a 5 midday and then a 3 in the evening before bed. Woke on March 31st feeling weak but was able to return to work with limitations in energy.
pt  w/11-12 cm area of erythema, warmth, itching @ inject site; no systemic sx
Erythema papular 6-8 on abd 2-3 on shoulder 8-10 on thighs some sl. vesicular 1 or 2 with scabs.
MMRV vaccine administered on 5/7/2020. Fever tmax 102.8 noted on 5/11/2020, patient was seen in the ER, no other signs of illness noted at the time. Patient advised to monitor Fever resolved on its own. Seen yesterday, 5/14 for routine follow up, patient well on exam. This morning 5/15/20, her mother noted a rash starting along her hairline, right chest wall. She has been more fussy than usual, otherwise, no other symptoms, adequate intake and wet diapers