chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache. Nausea, Blood pressure went up and arm swelled up. And my eyes was hurting really bad
Tired, sore arm for 7 days.  Bruising in leg the next day lasted for 10 days.  Chest pain went to urgent care 3 weeks later.
This spontaneous report was received from a physician assistant refers to a patient of unknown age. On 13-MAY-2009, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). On 21-MAR-2013, the patient was vaccinated with another dose of GARDASIL, (lot number, expiry date and route was not reported). Concomitant mediations were not reported. No adverse effects were reported. Additional information has been requested.
12/30: INDURATION, ERYTHEMA TO INJECTION SITE ON LEFT DELTOID; INCREASED ERYTHEMA AND WARMTH STARTED 1/7/21.
Patient came in for a covid vaccine. He received the Pfizer bivalent instead of the Pfizer monovalent. Patient had not received a covid vaccine before and should have received the Pfizer monovalent instead. Patient did not experience and side effects to the vaccine he received.
Post vax the patient developed a raised bump on his arm about the size of an egg in circumference. His skin felt leathery with a slight itch and redness.
Onset: inject site pain followed by fever, chills, body aches, malaise, and vomiting. 9/24 5 AM: headache, all other symptoms resolved. All symptoms resolved by mid-morning.
Patient received 2nd dose of COVID 19 vaccine series. Patient was supposed to receive Moderna vaccine and instead received Pfizer vaccine. No immediate anaphylaxis or other side effects were present after the patient received the vaccination.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing); "Keflex allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN, start date: 01Dec2016; OMEPRAZOLE, start date: 01Dec2019. 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: (13Apr2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 04Apr2023 to 09Apr2023.
It has been more than 36 from 1st dose, patient hasn't received 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 from 1st dose, patient hasn't received 2nd dose) 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 from 1st dose, patient hasn't received 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 from 1st dose, patient hasn't received 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: follow up information included No new information.
Fatigue; low grade fever (99.4); This is a spontaneous report from a contactable consumer(patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6204), via an unspecified route of administration in the left arm on 06Mar2021 at 09:30 as a single dose for COVID-19 Immunization. Historical vaccine included first dose of vaccine Pfizer BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number : EL9266) via an unspecified route of administration in the left arm on 13Feb2021 at 09:30 as a single dose (at the age of 68-years-old) for COVID-19 Immunization. The patient medical history included missing one kidney. Concomitant medication was Hydrochlorothiazide 25mg. Patient had no allergies. Patient did not receive vaccine in four weeks. On 07Mar2021, Patient experienced Fatigue and low grade fever (99.4). No treatment was given for the event. Patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Initial misuse report received from a healthcare professional on 18 October 2013. The cases were received on 21 March 2014. 14-year-old patient received dose of FLUZONE ID. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Muscle aches, (neck & lower back), headache, nausea, extreme fatigue, hives
Pfizer dose for 5-11 years was injected to upper right arm. While waiting in the clinic, my child said that feeling dazzle. then right after that felt off the chair, lost consciousness, and lay on the ground.  Dr. was beside us when this happened. Shortly the child awoke but was very weak.  Dr. called the nurse to bring a bottle of juice.  The child rest at the clinic patent bed for about 20 minutes and then went home.  This report is submitted 8 hours after this event. The child seems OK except not active as usual and complained that have a headache.
Vial was punctured on 8/16/21 and administered 8/25/21
Thinking and numbness in both hands in fingers mostly outer 3. Middle ring and pinky and numbness in both toes and feet. Weakness in fingers and hands
allergic reaction, immediate report to injector of having "Halo effect". was told to be observed for 30 minutes. Started having itching on her neck before 30 minutes had passed. By the time she got home she had swollen tongue, slight SOB, rash over more of her neck and body. fatigue, swelling near left eye. She called her primary and they started her on steroids.
Strong Headache for about 18 hours, and full body muscle ache for about 24-36 hours.
Injection Site soreness.; General body soreness; Nausea; Headache; Fatigue; Armpit sore on Arm of injection; Elbow achiness in arm of injection; Dose 3 received; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: PF8841) via an unspecified route of administration on 21Oct2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks prior to the vaccination. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine.  The patient previously took pentothal sodium (MANUFACTURER UNKNOWN) and experienced drug allergy. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 01Feb2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation and received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 11Jan2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. On 22Oc2021, the patient experienced injection site soreness, general body soreness, nausea, headache, fatigue, armpit sore on arm of injection and elbow achiness in arm of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site soreness, general body soreness, nausea, headache, fatigue, armpit sore on arm of injection and elbow achiness in arm of injection was unknown at the time of this report.
pt recvd vax; starting crying unconsolably; knot at inject site;apap did not help;PC to urgent care; advil given;
Day 3: Very tired; Day 2: Low grade fever and body aches; Day 2: Low grade fever and body aches; First 24 hrs: Arm hurt a lot; This is a spontaneous report from a contactable consumer (patient).  A female patient of unknown age received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EP6955 and expiry date: Not reported), via Intramuscular on 08Apr2021 at 10: 00 am on left arm as Dose 2, single for COVID-19 immunization. Medical history was not reported. No known allergies were reported. Concomitant medications included: paracetamol (TYLENOL) and calcium carbonate, colecalciferol (VITAMIN D 2000) within 2 weeks of covid vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EP6955 and expiry date: Not reported), via Intramuscular on 18Mar2021 at 10: 00 am on left arm as Dose 2, single for COVID-19 immunization and was tired in the evening of the same day. The patient did not receive any other vaccines with in four weeks prior of COVID vaccine intake. The patient was neither diagnosed with COVID prior taking vaccine nor been tested for COVID-19 Since the vaccination. The patients arm hurt a lot for the first 24 hours (08Apr2021) of taking second dose of vaccine and then had Low grade fever (<100F) and Body aches on day 2 (09Apr2021) of vaccination. The patient was very tired on day 3 (10Apr2021) of second dose of vaccination. The patient did not receive any treatment for all reported events. The patient got recovered from all the events on an unspecified date.  No follow-up attempts are needed. No further information is expected.
12/10/08 Reported persistent pain after flu shot.  Saw MD, was told injection "hit a nerve".  1/5/09 Pt reports receiving cortisone shots for bursitis.  Now starting Physical Therapy.
COVID-19 resulting in inpatient hospitalization of a vaccinated patient.  3rd dose of Moderna vaccine given 11/28/2021
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The caller was unable to provide the batch number and expiry date but could provide NDC number. The stated that after 1st dose of SHINGRIX the patient experienced arm hurting which resolved within 48 hours of injection. The permission was given to contact pharmacy and primary health care pharmacy. No further information was provided. This case has been linked with case US2018140216 reported by the same reporter for the same patient (case for 2nd dose).
Information has been received from a physician concerning a 12 or 13 year old female patient who was intramuscularly vaccinated with the second dose of GARDASIL vaccine on unspecified date. In March  or April 2008, the patient experienced with urticaria all over her body within 24 hours of receiving GARDASIL vaccine and returned to the doctor's office for medical attention. There was no wheezing. Subsequently, the patient recovered on an unspecified date and there were no follow up visits. Additional information has been requested
tired; Cough; Sinus drainage; Chills; Fever; Upset stomach; arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (many years prior to receiving the Shingrix vaccine) and shingles (many years prior to receiving the Shingrix vaccine).   On 22nd October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 22nd October 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 26th October 2021, the patient experienced tiredness, cough, nasal sinus discharge, chills, fever and upset stomach. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the tiredness, cough, nasal sinus discharge, chills, fever and upset stomach were unknown.   It was unknown if the reporter considered the pain in arm, tiredness, cough, nasal sinus discharge, chills, fever and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine in her left deltoid at her pharmacy and experienced arm pain after receiving the vaccine that lasted 3 days, and had since resolved in October 2021. Four days following her Shingrix vaccination, she felt tired, developed a cough, sinus drainage, chills, fever and upset stomach. The reporter stated that she was unsure that the symptoms she was experiencing this week were due to the Shingrix. The reporter could not provide the lot number and expiration date. The reporter consented to follow up.
Patient was given a HPV Gardasil 9 vaccine in error.     Pt was scheduled for PCV 13.   Providers office called Poison Control as soon as the error was identified  and collected any appropriate treatment information, then called the Parent for notification.
Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium
Had my first vaccine dosage on 3/26/2021, second dosage on 4/23/2021. I did last ultrasound on 4/22/201, baby was measuring 8 weeks and 4 days with a heartbeat of 174. The baby stop growing 9 weeks and 1 day on 4/26/2021.
Large swollen area on left upper arm. Hot, red, swollen, very tender to touch. Red area measured 5 inches in diameter.
Menses went from 2.5 days to 7 days. Pain and discomfort increased significantly. Blood lab work also showed minor anemia.
Pt describes following days after immunizations as becoming cold, shaking uncontrollably to the point she could not dial MD on her phone. She drove herself to the ED. Also, reported rapid breathing (like when having a panic attack and could not catch breath) as well as swollen arm from shoulder to elbow.
Pt recv vax on 4/3/97; on same day pt exp red/ swollen/ warm vax site; tx=Histamine blocker
Pain at sight of injection: deltoid muscle to the point I was not able to sleep on that side PLUS tender to touch.  The next morning, I had total body aches: muscles and joints, fever of 100.3-degrees, head ache, fatigue most the day. Upon calling the "nurse hotline" through  the nurse informed me that these were negative reactions to the COVID vaccine, that I could take Aleve or Tylenol and rest the rest of the day.  I was preparing lunch at the time. I went to take Aleve and finished lunch. Rested the rest of the day. This morning, 18 Feb 2021, I felt much better, however, the sight of the injection is still tender.
On February 14, I checked my Nexplanon birth control and could feel it in my left arm. Around February 15, I started getting some soreness around my nexplanon birth control in my left arm. I was able to get seen Student Health & Counseling on February 17. We noticed there was some swelling and bruising around my birth control and we could not find the nexplanon itself. We also noticed a little knot right next to my birth control as well. I was sent to the emergency room where they found the birth control and sent me home. I went back to the Student Health & Counseling to talk about my next options on getting it out on February 19th. We took some blood work to make sure everything was alright. My doctor was worried that the knot in my arm might have been a blood clot. She sent me to get an ultrasound where the Doppler said the knot looked like it was swelling. A few hours later, my doctor called me back and told me to go to the emergency room because my d-dimer levels were high. I went to the hospital, they took blood work again and everything came back fine. After a couple of days, the pain and swelling went down but it did cause my nexplanon birth control to migrate in my arm. I got the second vaccine on March 4. On March 5, I noticed soreness in my arm with a little swelling where my birth control was. While it wasn't as severe as the first time, I could definitely tell there was swelling and soreness. This lasted about 2 days.
Symptoms started around 7:30am and included pain where shot was given, redness and swelling where shot was given, mild fever, headache, tiredness, nausea, chills, sore joints, body aches.
received 3rd dose  inadvertently; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The pharmacist reported that a patient received a third dose of Shingrix inadvertently. The Vaccine Administration Facility was the same as Primary Reporter. The reporter was in the car at time of call, follow up for details via email. The reporter consented to follow-up. Additional supportive information: The patient received a third dose of Shingrix inadvertently, which led to extra dose administered.
This spontaneous report as received from a nurse refers to a 10 months 28 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Case number PHEH2014US015252 is an initial spontaneous report received from healthcare professional on 29 Jul 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: A13059) via subcutaneous route on 29 Jul 2014. No adverse event was reported following this administration error.
Patient had an injection site reaction which resulted in a shingles-like rash. It has been months since injection and she is experiencing postherpetic neuralgia at the injection site.
R arm, erythematous, hot to touch, edematous L arm 22.5 cm, R arm 27 cm. Lesion 19 cm x 13 cm. Hospitalized for IV abx and steroids.
Mild rash at site of inoculation. Slight itch, no treatment. Rash is 3 days old.
pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of BP cuff (4" x 10");this case was reported by a MD;cross reference w/DER0010150960093/96, DER 0010150960098 to DEr 0010150960102;
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored, oral, ROTATEQ (lot # K016314 and expiry date: 05-JUN-2016). No adverse effects were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
swollen lymph node in left side of collar bone and another one in right side inside groin; swollen lymph node in my left arm pit; little fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little fever), LYMPHADENOPATHY (swollen lymph node in my left arm pit) and LYMPHADENOPATHY (swollen lymph node in left side of collar bone and another one in right side inside groin) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PYREXIA (little fever). On 06-May-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node in my left arm pit). On 07-May-2021, the patient experienced LYMPHADENOPATHY (swollen lymph node in left side of collar bone and another one in right side inside groin). On 01-May-2021, PYREXIA (little fever) had resolved. At the time of the report, LYMPHADENOPATHY (swollen lymph node in my left arm pit) and LYMPHADENOPATHY (swollen lymph node in left side of collar bone and another one in right side inside groin) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. No treatment drugs were reported
swollen eyes; tingling lips; swollen throat; difficulty breathing; chills; involuntary twitching on the right side of her body; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. This female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient spent 4 hours in the hospital experiencing swollen eyes, tingling lips, swollen throat, difficulty breathing, chills, and involuntary twitching on the right side of her body. Treatment measures received including patient was given meds in IV solution and kept for observation. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
COVID vaccine lot 025L20A Patient reported to the nurse at her second COVID vaccine shot that her right eye became red and irritated 4 days after her first COVID vaccine. Patient reports that she called her ophthalmologist who agreed it was an allergic reaction to the vaccine.