chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report was received from a healthcare professional on 22 November 2011. A 65-year-old female patient had received an Intramuscular (IM) injection of FLUZONE HIGH-DOSE; lot number UH489AA in left deltoid and PNEUMOVAX; lot number 1138AA in right deltoid on 11 November 2011. On the same day of the injection, the patient complained of immense pain in her left arm with difficulty moving it. On Saturday, the patient went to the emergency room (ER) because the pain continued and the redness and swelling; she received corrected treatment with antibiotics. On Sunday, the patient returned back to the emergency room due to increased swelling and was given an antihistamine. On 16 November 2011, the patient arm was still sore, but the redness and swelling resolved. No further information was available at the time of the report. The patient outcome for pain in arm with difficulty moving was reported as unknown. Follow-up information was received from a healthcare professional on 24 January 2012. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
Flushing, Migraine occurred almost immediately after injection. Within 24 hours, severe muscle spasms, tremors, weakness, and continued migraine.
12 yr old attendee, upon receiving the injection, immediately went limp in his chair, slumping without injury. Vaccine RN called for assitance and medication; EMS initiated and arrived by 1217pm pst.  However attendee was alert and oriented by this point.  EMS arrived, monitored, vital signs were within normal ranges.  EMS departed at 1230 Attendee remained in observation for additional 30 minutes without further incident
I was given 3 doses of GARDASIL by nurses at the Student Health Center when I was 25-26 yrs old in 2014-2015. The last dose was in June 2015. In Dec 2015 I was diagnosed with thyrotoxicosis, ending up in hospital in the ER for 3 nights at Hospital. The symptoms after vaccination were: extreme tiredness, lack of focus, lack of concentration, memory loss, high pulse, migranes, anxiety.
pt recv vax 25SEP97 & 5OCT97 pt devel an inj site rash w/heat & tenderness;
On 03/26/2021 I received my first vaccination of Moderna (Lot # 016B21A - Exp 09/13/2021. After the shot I broke out in a terrible rash and had difficulty breathing (wheezing) shortly after getting the shot (late afternoon) and it got worse the next day.  I did research online and the recommendation was to not get the second shot if I experienced these symptoms.  I did not seek medical treatment but followed the CDC guidelines.
Pt had large area on (R) bicep of induration like hives, vaccine was given in proper place (R) deltoid. Also (L) arm had 4cm area induration at vaccine site.
Once the HPV vaccine was administered the patient started to feel dizzy, said that his vision has become blurry and that he felt numbness through his whole body. Blood pressure was taken at the time and it was 84/82. It was recommended to the patient to remain seated and after a few minutes the patient said he was feeling better.
This spontaneous report was received from a pharmacist and refers to a 13 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. The patient initially started on a 2 dose regimen for GARDASIL 9 then was shifted to a 3 dose regimen as schedule was off for 2 dose regimen. On 19-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot # and expiry date were not reported), on 21-SEP-2016 with the second dose and on 18-JAN-2018 with third dose. No adverse effects were reported.
eyes still look terrible; eyes watering; eyes itch; eyes are on fire; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eyes are on fire), EYE DISORDER (eyes still look terrible), LACRIMATION INCREASED (eyes watering) and EYE PRURITUS (eyes itch) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced EYE IRRITATION (eyes are on fire). On an unknown date, the patient experienced EYE DISORDER (eyes still look terrible), LACRIMATION INCREASED (eyes watering) and EYE PRURITUS (eyes itch). At the time of the report, EYE IRRITATION (eyes are on fire), EYE DISORDER (eyes still look terrible), LACRIMATION INCREASED (eyes watering) and EYE PRURITUS (eyes itch) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
lost frontal head hair plus mode thinning of balance; lost frontal head hair plus mode thinning of balance; remaining hair became very brittle and course; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), on 07Feb2022 as dose 4, (booster), single (Lot number: FK9729) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: ALOPECIA (non-serious), ALOPECIA (non-serious) all with onset Feb2022, outcome "unknown" and all described as "lost frontal head hair plus mode thinning of balance"; TRICHORRHEXIS (non-serious) with onset Feb2022, outcome "unknown", described as "remaining hair became very brittle and course".  No follow-up attempts are needed. No further information is expected.
BLOOD CLOT IN LEG; BLOOD CLOT IN LUNGS; This spontaneous report received from a patient via social media through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in leg, and blood clot in lungs. As per reporter, "Just want to thank you guys personally for giving me a blood clot not only in my leg but now my lungs. Should never of gotten the vaccine with you guys." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot in leg and blood clot in lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220250709-covid-19 vaccine ad26.cov2.s- Blood clot in leg, blood clot in lungs. 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). Therefore, this event(s) is considered unassessable.
Information has been received from a consumer concerning a 77-year-old female, with no pertinent medical history, who on 03-DEC-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX.  Concomitant therapy included diltiazem hydrochloride (TAZTIA XT), valsartan (DIOVAN), fluticasone propionate (+) salmeterol xinafoate (ADVAIR), "provanto", oxybutynin01 (OXYBUTIN) and pantoprazole sodium (PROTONIX).  On 05-DEC-2007 the patient experienced swelling at injection site.  The patient did not seek medical attention.  No diagnostic labs were performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
Information has been received from a pharmacist referring to a 62 year old female patient with drug allergy to penicillin. There was no pertinent medical history. On 25-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (lot # L046897, expiration date 23-FEB-2017, subcutaneous). Concomitant therapy included multiple unspecified medications. The patient had "injection site pain and joint pain in the left knee for the past week". There were no diagnostic lab studies performed. The outcome of injection site pain and arthralgia was reported as not resolved. Additional information has been requested.
Swelling, redness, and itching of eyes with exudate; swelling of throat, severe headache.
This spontaneous report was received from a medical assistant, concerning an unknown number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored ROTATEQ (lot #, expiration date, strength and dose, were not reported), administered orally for prophylaxis. The storage temperature excursion was reported as 1.2 degrees Celsius (°C) for a time frame of 4 hours and 3 min. There was no previous temperature excursion. No adverse effects were reported in any patients. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008770: US-009507513-1705USA001817:
Eye pain after the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Eye pain after the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (Eye pain after the shot). At the time of the report, EYE PAIN (Eye pain after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Narrative:  93 year old male with underlying dementia and a Slums score of 1 as of July 1st 2021 present to facility for worsening weakness and diarrhea for at least 4 weeks per patient's daughter. Patient is unable to participate in the HPI due to underlying cognitive status. The daughter endorses that the patient is unable to answer questions very well at baseline and there has been no worsening mental changes prior to admission. Per the daughter patient has been getting progressively weaker over the last few days. At baseline he is able to use a walker but today she endorses that he is unable to sit errect on the commode and is unable to stand up using a walker or hold on to the wall during ambulation which prompted her to call EMS. Upon work up patient was noted to have covid 19 on respiratory biofire. Per the daughter patient had no respiratory symtpoms. He was brought to the ED approximately one month ago and was negative. He has been fully vaccinated for this but has not yet recieved a booster. Also upon workup patient's creatinine was noted to be 1.5. He has underlying CKD but presenting renal function is elevated from baseline. admit for further review
The patient was given the wrong diluted COVID vaccine. The pediatric COVID vaccine for 6 months to  4 years of age was diluted with only 1 ml of Normal Saline versus the 2.2 ml that is required. Patient received .2 ml of this wrong diluted vaccine.
Pt recvd vax & following the vax lab eval revealed non-immunity to measles; No further details were provided;
Friday- patient had no strength; Saturday- nausea, vomiting, fever, body chills; Sunday- swollen armpit on side of injection; Monday- swelling still present but subsiding. Patient took OTC ibuprofen and acetaminophen- swelling was going down.
Prolonged joint pain; Prolonged muscle pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Prolonged joint pain) and MYALGIA (Prolonged muscle pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 ARTHRALGIA (Prolonged joint pain) and MYALGIA (Prolonged muscle pain). At the time of the report, ARTHRALGIA (Prolonged joint pain) and MYALGIA (Prolonged muscle pain) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-211604, MOD-2021-211592 (Patient Link).   Reporter did not allow further contact
Neuropathy; GBS; This case was reported by a other health professional via sales rep and described the occurrence of neuropathy in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant) and guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the neuropathy and guillain barre syndrome were unknown.   It was unknown if the reporter considered the neuropathy and guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The reporter had third hand information about the case from  the clinic. The reporter did not wish to be contacted. It was reported that, the case had been reported to VAERS and the reporter was unaware of the outcome. This case is 1 of the 3 cases reported by the same reporter.
Fever, redness, itching, pain, and large amount of swelling in the injection site. It started 4hrs after the injection time and now 7 days later it is still in the same condition other than now I?m no longer experiencing pain.
Within 2 days of administration of vaccine developed erythematous warm annular patch at site of injection - area tender to the touch.
Redness, swelling and extreme pain.  Started right after injection and it continues as of today.  She was started on Keflex at first and is now on amoxicillin.
This is a spontaneous report from a contactable Other HCP (patient). A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 at the age of 41-years-old (Lot Number: ER8731) as single dose for COVID-19 immunization. Relevant medical history and concurrent conditions was none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously took amoxicillin and experienced Known allergies: Amoxicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported: "I broke out in a rash on 17Apr2021. It started on my face in a straight line down my left cheek and neck. Then it appeared in patches on my trunk (both stomach and back). It eventually spread to my legs. I got new patches for 2 weeks following the shot. I went to the doctor and they couldn't prescribe steroids as it was stated that it would lesson the effects of the second shot. When I started my menstrual cycle 3 weeks following the 1st dose of my Pfizer shot I had severe cramping and clotting for 3 days during my period. It was the most pain that I have had from a period. The flow was stronger from the beginning of the cycle than is typical." The adverse event result in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered in 2021.; Sender's Comments: Based on temporal association and known safety profile of the product, there is a reasonable possibility that th event rash is related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Taken by ambulance from home to ER on Sunday, March 21, around 7:30 pm. Symptoms were severe head and leg pain, vomiting and diarrhea. X-rays and blood work taken. Given pain medication and fluids. Dr in ER said it could be a virus. Discharged at midnight Monday 22. Followed up with my primary.
heart is racing; face felt hot; irregular heartbeat; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left shoulder on 06Jan2021 at a single dose for covid-19 protection. Medical history included with irregular heartbeat (diagnosed years ago). There were no concomitant medications. The patient stated that his heart was racing. He was sleeping and woke up to heart racing 130-140. He had irregular heartbeat and his face felt hot the morning of 07Jan2021. He did not know if it was his heart, nerves or what. was his first dose. He got the vaccine on his job and stated that sometimes his heartrate goes up and down not to this magnitude and not while sleeping. He had asked one of the nurses during vaccination about having irregular heartbeat and taking the vaccine and was told that one could die of much worst than this. Patient wanted to know if he should go to the doctor and what to do. Outcome of the event heart racing was recovering while for face felt hot was recovered on the same day of 07Jan2021, and for the remaining event was unknown.  Information on the lot/batch number has been requested.
pt recv vax 4NOV97 & same day pt exp a burning sensation & discomfort in arm;next day pt recovered;
swelling at the injection site; pain in arm; headache; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on 21Feb2021 (Lot Number and expiration date was not reported) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient reported that she had swelling at the injection site, pain, and headache. She also reported she did not have any fever, stated that she had a headache and a swelling where they gave a shot, her arm swelled and that was about it. She had a lot of pain first day she could not even lift her arm and a day after she mean at night, and then it got a little bit better next day and she still had a pain she was lifting and moving her arm, left arm. All the events occurred on an unknown date in 2021. She was scheduled to get her second dose of the vaccine on 19Mar2021. The outcome of the event pain in arm was resolving and all other events was unknown.  No follow-up attempts are possible. No further information is expected.
This case was reported by a physician and described the occurrence of cellulitis in a patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed (Infanrix).  The physician reported that the adverse event occurred in several patients, however, no patient identifiers were provided.  Upon follow up, only one patient was identified.  On an unspecified date, the patient received the last dose in the vaccination series of Infanrix (lot DTPA627A2).  At an unspecified time following the administration of Infanrix, the patient experienced cellulitis and a local reaction.  The events resolved.  The location and treatment of the reported events were not specified.  The physician considered the events to be nonserious and to be related to vaccination with Infanrix.  The physician stated that this report was initially reported as a potential quality assurance problem.    Comment:  Cellulitis was assessed as medically serious by GSK.
Pt. developed lump on left shoulder / trapezius 1 day after intradermal shot.
Same day:  Ear Ache, ringing, clicking ear sound when swallowing, dizzy, fibromyalgia  pain  exasperated  Today 04/13/21: Same as day one
veritial / face feels like frozen/ hard to breath/mentally could not control myself/screaming/living in another word  for more than 2 hours
Sore throat; Sweats; 100.1 fever; Pain at injection sight; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 21Apr2021 at 09:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included kato dietary supplement which was unspecified from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 22Apr2021 at 04:00, the patient experienced 100.1 (units unspecified) fever, sweats, pain at injection sight and sore throat. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events 100.1 (units unspecified) fever, sweats, pain at injection sight and sore throat was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
no adverse event; Medical assistant reported ROTATEQ  was administered after temperature excursion. See full details below. No additional AE/no PQC.  ?    Names of vaccines involved ROTATEQ 1968393 05/24/2024 ?    Temperature 8.9°C (08/14/2023) and 9.4°C (08/28/; This spontaneous report was received from a medical assistant and refers to an unknown age and gender patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-SEP-2023, the patient received the improper storage vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1968393, has been verified to be a valid lot number, expiration date was reported as: 24-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided) (improper storage of product in use). The therapy was storaged 12 hours 20 minutes 0 seconds with temperature 8.9 degrees Celsius on 14-AUG-2023 and 8 hours 20 minutes 0 seconds with temperature 9.4 degrees Celsius on 28-AUG-2023. No additional AE/no PQC.
PATIENT'S HAND BEGAN TO SWELL SOON AFTER RECEIVING THE VACCINE. IT WAS REPORTED TO PHARMACIST 1 WEEK LATER. THE SWELLING HAD IMPROVED A LITTLE BY THAT TIME.