chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left 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: "Crossover Psoriatic Arthritis" (unspecified if ongoing); "Rheumatoid Arthritis" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE. Past drug history included: Rybelsus (same reaction), reaction(s): "known allergies"; Azithromycin, reaction(s): "pin prick rash"; Codeine, reaction(s): "severe heartburn". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Anti-viral details, Product: COVID-19 Treatment, Brand: Paxlovid, Treatment start date: 18May2022, Treatment stop date: 19May2022, Lot number: GA1189, Indication: Treatment of COVID-19. It was reported that patient received other medication within 2weeks. Additional information: After the first dose- Severe dysgeusia after 1 hour of the first dose. The taste was so bad that it was difficult to sleep. After the second dose- small very itchy bumps appeared on chest, near belly button, left leg, left arm, side and head. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Administration error: A 47-year-old male patient received second booster dose of the Pfizer vaccine, which is only authorized for patients over 50 years of age and immunocompromised patients.
Painful and swollen lymph nodes under the arm and on neck of same side of vaccine. Had a previously scheduled screening mammogram performed 2/6/2021. Mammogram tech was notified by myself of swollen nodes and recent Covid vaccine. She said to go ahead and get the mammogram. Radiologist who read the mammogram saw swollen lymph nodes and advised follow up ultrasound of axilla (Left- which is the same side I received the vaccine). Ultrasound done 2/17/2021 should mild lymphadenopathy, so now I find myself be advised for ANOTHER ultrasound in 4-6 weeks to assure resolution. Although my lymph nodes are much less swollen and painless at this point (almost 3 weeks post 2nd Moderna vaccine).
pt recv vax & devel chickenpox starting 5/9/99 w/last lesion 5/20/99;mild case w/no complications;
Myositis (L) arm at time of injection. Also occured in 2013 per pt, but not evaluated medically.
Swelling, redness, streaks of red throughout upper arm, extreme muscle pain, fever, body aches, headache.
Shortness of breath. BP 145/91 (pulse 70), 95% O2 sat.
stated that she had a headache; stated that she had a little bit of muscle pain; This is a spontaneous report from a contactable consumer, the patient. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 1 on 19Jan2021 for COVID-19 vaccination.  Relevant medical history was unknown.  Concomitant medications were unknown. On an unknown date, the patient had headache and a little bit of muscle pain. It was unknown if the patient received treatment for the events. The clinical outcome of headache and a little bit of muscle pain was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Client was given dose for 6 mo - 4 yrs instead of 5 - 11 yrs.  No adverse outcome reported. Dose not yet repeated at this time.
Client experienced syncope approximately 5 minutes post vaccination.  States the last thing he remembered was "feeling hot".  He fell from his chair in a seated position in the post vaccination observation area onto the floor.  Client was noted to be pale upon arrival to the scene and he was trying to stand up from the floor.  Assisted client to a seated position on the floor.  He was provided juice which he tolerated and stated he felt better within 1-2 minutes.  We observed him in clinic for an additional 20 minutes and he left independently with no complaints.
This patient presented to the emergency department with shortness of breath, cough, fevers, and generalized weakness. Patient tested positive for COVID-19 on 8/28/2021 and was hospitalized for 4 days until she ultimately expired after experiencing a NSTEMI during admission.
12 hours of vomiting, fever, chills, sweating on palms and soles of feet, headache, trouble moving arm, muscle aches, knot on arm. No treatment the muscle aches, headache, and trouble moving arm lasted about 3 days.
Patient  received both the Boostrix and Fluzone Quad vaccinations administered by pharmacy intern. Sat in a chair outside the pharmacy for his 15 minute observation. after less than a minute, his friend yelled for help as he was visibly fainting and very pale. I responded to help the patient and lowered him flat on the floor and elevated his feet. He came to and started responding within 30 seconds to 1 minute after I got out to him. While I was taking care of him, my other pharmacist called EMS. I started conversing with him and he was coherent. He reported feeling a bit shaky still. I explained that it was likely a vasovagal response and that I would stay with him until he felt better. EMS arrived After about 5 minutes and took vitals, which were normal. Patient opted to decline ambulance transportation. They did decide to go to urgent care to be seen after the event. When patient left he had his color back and was conversing normally and his shakes had gone away.  15-20 minutes after event patient felt back to normal and left the store.
Sixty minutes post vax, this pt developed coughing and tightness in the chest. She was pretreated with antihistamines the day before and treated with epinephrine and albuterol inhaler post immunization. The physician reportedly feels that the adverse reaction is latex related.
1/2/2021 1125 reported tingling of tongue and lips.  Reported top lip was swollen.
Minor rubella rash about 1 week after vaccine. Also joint pain, 1gm positive. Rash and joint pain subsided.
After vaccines, ate well and took a nap. Abuptly woke up screaming with a high-pitched cry (not his normal cry) "like he was in severe pain," arching, and intermittently inconsolable/very sleepy. Per mom, he "stopped breathing and turned white" once as well. Temp 100.2. Was high-pitched crying, extremely irritable, arching, alternating with being very sleepy and hard to arouse. I sent them to the ER via ambulance.
pt recv 1st vax; devel fever,lasted x 5 wk;recv 2nd vax, devel low grade fever of 99.7 & exp fatigue; sx persisted for approx six wk;
information has been received from a physician concerning a 6 year old male who 09/12/1999 was vaccinated with a dose of varicella virus vaccine live. The pt was seen after the development of a papulovesicular rash on his left thigh which was DX as shingles on 02/01/2005. Prednisone and Zovirax were RX. There was no information provided regarding the pt's present  status. No product quality complaint was involved. Additional information is not expected.
arm hot at injection site; arm red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (arm hot at injection site) and INJECTION SITE ERYTHEMA (arm red at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE WARMTH (arm hot at injection site) and INJECTION SITE ERYTHEMA (arm red at injection site). At the time of the report, INJECTION SITE WARMTH (arm hot at injection site) and INJECTION SITE ERYTHEMA (arm red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication use was provided by the reporter. Treatment of events was not reported.
pt recvd vax; t of 102-104 p/ each dose; 5 days p/ 4th dose, felt strange, hallucinations,"passed out", numbness & tingling in legs; next am felt fine;
Patient felt dizzy, hot, nauseous and subsequently fainted approximately five to ten minutes after vaccine administration. He regained consciousness within a few seconds. They had him lay on the floor with feet elevated. Dizziness and lightheadedness resolved. He remained under observation for 30 more minutes.
This spontaneous report was received from a male patient of unknown age referring himself. The patient's pertinent medical history was not reported. On an unknown dates, the patient was vaccinated with first two shots of GARDASIL, five weeks apart. No adverse effect was reported. No product quality complaint (PQC) was reporred for GARDASIL. Additional information is not expected as the contact details were not reported.
Initial health care professional report received on 02 Mar 2011: This patient received first dose of RABIPUR (batch number 468013A) intramuscularly into the upper arm on 21 Jun 2010. The patient also received co-suspect, TWINRIX, (batch number AHABB191AC, other manufacturer) intramuscularly into the upper arm on 21 Jun 2010. On 22 Jun 2010 at 5 am, the patient developed thoracal syndrome with dyspnea. The patient was hospitalized on the same day. On 15 Jul 2010, the patient received the next vaccination with RABIPUR (batch number 474011A) without any complications. On 22 Jun 2010, the patient recovered from the events. No causality assessment was reported. Following internal review on 10 Mar 2011 of the information received on 02 Mar 2011, it was noted that the event verbatim term "thoracal syndrome" was incorrectly reported as thoracic outlet syndrome. Therefore, it was corrected to thorax pain.
Narrative: COVID infection following COVID vaccine series 04/26, Pfizer, dose #1 05/21, Pfizer, dose #2 08/12 COVID swab, result: detected 08/12 pt cc: exposure: unknown
TD administered 9/16/02. 9/20/02 left deltoid swollen and painful with pain radiating down arm, fingers becoming numb. I&D with minimal drainage done, culture sent out. Given Keflex 500mg, Vicodin, Naproxin 250mg
after the 2nd shot I had shingles/suspected vaccination failure; light case of the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 30-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got his/her shots and guess what, after the second shot, had a light case of the shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Heart rate in the  130s for a number of hours, weakness to the point my knees started to buckle, headache, extreme nausea, inability to urinate for a number of hours. Started to improve but later had a temp of 104.1, used ibuprofen to lower temp
headache; heart-pounding, racing heart beat,; dizziness; feelings of passing out; This is a spontaneous report from a contactable consumer. A 66-year-old non-pregnant female received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL9262), via an unspecified route of administration in the left arm on 23Jan2021 10:00, at 0.3ml, single for covid-19 immunization.The patient medical history was not reported. Patient is an Rh Neg A blood type and did not have Covid, as she's been isolated for a year.  Concomitant medication included gabapentin, paroxetine hydrochloride and atorvastatin. On 23Ja2021, after half an hour (10:30) of receiving 1st dose of the vaccine, patient experienced heart pounding, racing heart beat, dizziness, feelings of passing out. These symptoms lasted up to 3 hours. Patient sat her my car outside of the an emergency parking lot for 3 hours because she couldn't drive home during these symptoms. Patient was on the verge of going into emergency care. For the remainder of the day, patient's sitting heart beat was at 90. The next day, 24Jan201, she felt better but have on and off slight headache. She did not plan on taking the 2nd dose. The outcome of the events was recovering. The patient has not tested positive for Covid-19 post vaccination.
Feeling dizzy, drop in blood pressure, white face, almost fainted. Feeling nauseous. Had just left doctors office.  Rushed back to Drs., they had him lay down and monitored him and took blood pressure, which was low.  Observed him until he felt well enough to leave.  Patient felt cold on the way home and tired for the remainder of the day.
Extreme joint pain and muscle pain more than one week post vaccine.  Feeling of being overheated more than one week after vaccine. No treatment, can?t afford dr visit.
Administered vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 60-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 60 year old, male patient.  The patient's medical history is not provided.  The event occurred on 28 Dec 2020, when the patient was given the first dose of the mRNA-1273 (Lot: 025J20-2A) . This report refers to a case of storage error where refrozen mRNA-1273  has been administered to the patient.
1) My dad was terribly ill from 2am-7pm the day following vaccination (fever, chills, muscle and joint aches).  He reported suicidal ideation for the first time in his life.  This ideation passed by the following day. 2) The injection was done high in the deltoid, and he reports severe pain in the left shoulder joint with use.  This pain is still present, and he reports that today (4/21/21) is the worst day yet:  "My shoulder is almost unusable."
Vomiting, nausea, fever, severe back pain, other myalgias, headache
had sore arms; minor body aches; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (had sore arms) and MYALGIA (minor body aches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy and Blood cholesterol abnormal. Concomitant products included ROSUVASTATIN for Hypercholesteraemia.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In 2021, the patient experienced PAIN IN EXTREMITY (had sore arms) and MYALGIA (minor body aches). The patient was treated with IBUPROFEN at an unspecified dose and frequency. In 2021, PAIN IN EXTREMITY (had sore arms) and MYALGIA (minor body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient height was reported as 6 feet and 4 inches.  Patient received dose 1, dose 2, dose 3 and dose 4 of Moderna vaccine. Patient was healthy and active. Patient did not seek medical care for AE cause. Patient did not experienced a similar event in the past.   This case was linked to MOD-2022-658064, MOD-2022-658071, MOD-2022-658065 (Patient Link).
Chills low-grade fever runny nose headache Starting 24 hours after vaccine and lasting 48 hours or less
Had possible seizure while in the car.  Taken by EMS to Hospital - normal eval there.  Will be undergoing EEG and MRI in the future.
couldn't move my arms; couldn't move my arms; This is a spontaneous report from a Regulatory Authority received from a contactable Healthcare Professional. A 53-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on an unspecified date, at 53 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization and palbociclib (IBRANCE), oral from Mar2021 and ongoing (Batch/Lot number was not reported), at 125 mg, cyclic daily for 21 days on and 7 days off for breast cancer. Medical history included breast cancer from an unknown date and unknown if ongoing. The patient's concomitant medications included exemestane daily in conjunction with palbociclib. The patient reported that the first vaccine dose was really bad and she couldn't move her arms since an unknown date. The patient reported that the most recent blood work (date unknown) "looked okay". In response to the events palbociclib dose was not changed. At the time of the report the events outcome was unknown.  Information about batch/ lot number has been requested.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 22-year-old female subject who was vaccinated with BOOSTRIX, GlaxoSmithKline. The subject had no relevant medical history and there were no known adverse events following previous vaccinations. Concurrent medications included TRINESSA. On 19 May 2009 at 16:45 the subject received booster dose of BOOSTRIX (0.5 ml, unknown route, left deltoid). On 21 May 2009, 2 days after vaccination with BOOSTRIX, the subject experienced injection site redness, warmness to touch at injection site and injection site soreness. The redness measured approximately 4.2 centimeters by 4.5 centimeters wide, and had improved by 22 May 2009. At the time of reporting the warmness to touch and soreness at injection site were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow-up information was received on 17 August 2009 from the reporting nurse practitioner. BOOSTRIX was given intramuscularly. The subject was allergic to penicillin and sulfa drugs. The subject had no alcohol or tobacco use. Diagnosis was reported as local skin reaction to BOOSTRIX which began on 21 May 2009. The events resolved on approximately 24 May 2009. The nurse practitioner considered the events to be possibly related to BOOSTRIX. The nurse practitioner reported that the events were not serious; however, the nurse practitioner indicated that the events were clinically significant or requiring intervention; the subject was seen and over-the-counter ibuprofen, ice and heat were recommended.
Headache in "forehead". Nausea - no vomiting.  Onset 01/05/09
Described extreme soreness and redness at injection site, Right Deltoid. Difficulty lifting Right arm for one week following injection, with induration at spot (no pain) 3 weeks after.
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 04-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.  ; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Within just a few minutes my arm began to itch, burn and turn red and immediately got hot.  A lump appeared.  Began to itch more as time went on.  The pharmacist gave me Benadryl liquid..it helped temporarily, but that night swelled around 1/2 my arm and this went on for at least 4 days. Called my Dr. and he said wait another day as it could be abscessed..however, it has subsided but not completely to this date, still some irritation.