chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received vaccine on 10/27/2010. Called pharmacy on 11/3/2010 complaining of arm pain from shoulder to elbow with no relief. Pt has been treating with TYLENOL and Ibuprofen. Will f/u with patient. MD notified 11/3/2010 advised pt to apply heat, treat with TYLENOL and Ibuprofen.
Itchy skin swollen hands and feet.  Can't quit itching.  Started 2-3 hrs after injection; continues 5 days post; swelling gone on this date.
Severe nausea. Unable to keep down ANY liquids including water for the first 24 hours after the vaccine was administered. Uncontrollable sweating (no fever), muscle spams near vaccine site on left arm and in left shoulder blade. Headache.
Caller had noticed numbness around the life side of her body including the left hand and fingers; Tingly from her scalp to the bottom of her foot; Numbness around the life side of her body/The entire left side of her body, unilaterally, went numb; This is a spontaneous report from a contactable consumer. A 77-year-old female consumer received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration on Arm left on 23Jan2021 (Batch/Lot number: EL3249), as 1ST DOSE, SINGLE for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient reported, she noticed numbness around the left side of her body including the left hand and fingers. The fingers are more numb than any other part of the body on 23Jan2021. She states My doctor thinks it's some kind of a vascular or neurological event. He doesn't recommend the second dose. I want to know if these side effects were associated with the vaccine. The entire left side of her body, unilaterally, went numb and tingly from her scalp to the bottom of her foot. It was first noticed in the hand. She called (Emergency number) as she feared a stroke. They said it was not a stroke. Her hand is still considerably dumb and she has lost some of its use. This occurred approximately 7 hours after getting the vaccine. It has improved. Everything is back to normal besides her left arm from where she got the injection leading down to her hand. Her hand is the worst. The outcome of the events for numbness in hand was unknown and for rest of event it was resolving.  Follow-up attempts are completed. No further information is expected.
pt recvd vax 29JUN94 & was seen in ER 29JUN94 & 1JUL94 w/persistent fever 104 R-49 hrs temp; large induration to inject site
Syncope, lower extremities elevated, provided with moist compress, vital signs remained stable. Monitored for 30 minutes, patient alert and oriented. Patient reported that he had not eaten prior to vaccines.
Reported Symptoms: NO ADVERSE EFFECT; DRUG ADMINISTRATION ERROR; Narrative: VACCINE ADMINISTERED IN ERROR - Patient administered Moderna Bivalent COVID booster in clinic 1/23/23. Patient previously received a Pfizer booster 12/2022 (exact date unknown) at an outside location which was missed by nurse
pt admitted to hospital with worsening SOB and cough; had a positive COVID test (outpatient) and was prescribed Paxlovid; tested positive again in hospital for COVID; O2 supplementation; worsening renal function; pt's respiratory status was worsening as well; needed NIV; while discussing this with the pt, he had a seizure, became hypoxic and hypotensive; while getting ready to intubate, pt lost pulse; ACLS efforts with chest compressions started without success; pt passed away in the hospital
Experienced extreme fatigue, headache, high fever and arm soreness for 48 hours.
Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who was vaccinated with a dose Gardasil (date and dose not specified). The physician reported that the patient experienced dizziness after receiving the vaccination, and subsequently, recovered (duration not specified). Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Initial and follow up information has been received from a physician, concerning a 12 year old female patient, with no pertinent medical history or illness at the time of vaccination, who on 18-JAN-2007, was vaccinated IM in the right arm, with the first dose of GARDASIL (Lot #654540/1162F). Concomitant therapy included an IM vaccination in the left arm with the first dose of MENACTRA (Lot #U2159AA). The physician reported that the patient became dizzy/lightheaded, felt weak, and became very pale after receiving the vaccination. The patient was helped to a chair, and kept closing her eyes; she was then helped to lie down. Her blood pressure and blood glucose were "within acceptable limits" (values not provided), but each time she tried to get up, she would feel dizzy again and had to lie back down. She was given juice, and within approximately 15 minutes, she had recovered and was able to leave. No futher information is expected.
Localized redness and warmth around injection sites <24 hours after vaccines persisting for > 48 hours.
Patient reports that arm became red and painful and itchy starting the night of the shot.  She states it got worse the next day so she finally called her doctors office.  She took some benadryl during this time which she said helped some with the itching.  She was seen at the doctors today and given doxycycline for cellulitis.
thrombocytopenia; red dots on her body, like freckles, throughout the body, was diagnosed with thrombocytopenia; Initial information received on 26-Sep-2019 regarding an unsolicited valid serious case received from a pharmacist in the.   This case involves a 32 years old female patient who experienced thrombocytopenia (thrombocytopenia) and red dots on her body, like freckles, throughout the body (Ephelides), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Bacterial infection (patient had been fighting a bacterial or viral bug for the last month, and she thought it was could have been pneumonia) and Malaise (had been sick for a month on and off).  The patient's past vaccination(s) included flu vaccines. The patient's past medical treatment(s) and family history were not provided.  On 24-Sep-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ209AB, Exp. Date 30-Jun-2020 via intramuscular route in the left arm.  On 25-Sep-2019, the patient developed a serious thrombocytopenia (thrombocytopenia) and red dots on her body, like freckles, throughout the body (Ephelides) one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This events were assessed as medically significant. The patient was hospitalized for these events.  Other relevant tests not reported. It was reported hematologists were conducting more tests  Final diagnosis was thrombocytopenia.  An unknown corrective treatment was received. Patient received a blood transfusion  The outcome was unknown for thrombocytopenia and Ephelides.  List of documents held by sender: none.; Sender's Comments: This case involves a 32 years old female patient who developed thrombocytopenia one day after vaccination with FLUZONE QUADRIVALENT. Time to onset was compatible. The patient's past medical history included Bacterial infection (patient had been fighting a bacterial or viral bug for the last month, and she thought it was could have been pneumonia) and Malaise (had been sick for a month on and off) and weaken immune system due to infection is common cause of thrombocytopenia. Therefore, additional information including patient's medical condition at the time of vaccination, lab test excluding other etiologies are needed for further assessment of the case. Based on the available information, the role of vaccine cannot be assessed.
Information has been received from a registered nurse concerning a 63 year old female with drug reactions/allergies to aspirin, nonsteroidal anti-inflammatory drug (unspecified) and CELEBREX who on 13-AUG-2008 was vaccinated intramuscularly in the left arm with a 0.5 mL dose of PNEUMOVAX 23 (either Lot# 659150/1384U or 658673/0990U). The nurse reported that the patient developed injection site arm pain the same night of the vaccination. The pain kept the patient up the whole night and was described as extreme. There was no redness, no warmth, and no swelling reported at the injection site. The patient's experiences were considered to be disabling. The nurse requested lot checks for both of the reported lots. Additional information has been requested.
PIP at injection site- 48 hours Fever- 102.6- 36 hours Chills- 24 hours Muscle and joint aches- 48 hours Severe Headaches- 48 hours
No adverse event or signs happened at the time of administration but a month later patient's boyfriend called and reported death of patient because of lump under the skin at site of injection.
About 3 weeks after my second Pfizer Covid-19 shot, I experienced itching on the chest. I had thought it was poison ivy and did not address it initially. It did not follow the usual course of poison ivy as it was scabbing over and the itching got worse. I thought that it could be shingles and I made an appointment to see my GP. She said that it was a mild case of the shingles and she could not give me the anti viral medication because it had scabbed over. She told me to take an anti itching cream as well as Tylenol and that helped.
SOB, cough with clear sputum, nausea and diarrhea, subjective fevers and chills.
Symptom onset 4/12/21 (cough, diarrhea, feverish, nausea, chills, fatigue and abdominal pain). 4/14/21 PCR positive for COVID-19 virus. Admitted inpatient 4/14/2021.
10 days p/vax pt devel rash & temp to 101; seen in ER, rash dx as coxsackie; still w/rash
WITHIN 10 HOURS, SEVERE HEADACHE, HAD FLU LIKE SYMPTOMS FOR APPROX. 2 WKS. FOLLOWED BY HEADACHE, SHORTNESS OF BREATH, WHEEZING. PRESCRIBED ALBUTEROL INHALER TYLENOL Z-PAC. FEW MONTHS LATER WENT TO IMMEDIATE CARE WITH ACUTE BRONCHITIS - TUSSIONE X COUGH SYRUP, MUCINES. USE HUMIDIFIER, CONTINUE INHALER 11/27/2022 - IC ASTHMATIC BRONCHITIS W/ACUTE EXACERBATION ACUTE COUGH, WHEEZING. PRES. ALBUTEROL SULFATE - HFA INHALER, PREDNISONE TYLENOL. 1/29/23 - URGENT CARE - ACUTE PANSINSITIS, BRONCHITIS. PRES. CEFDINIR AND PREDNISONE - CONT. ALBUTEROL SULFATE INHALER. 3/14/23 - ER. UNABLE TO BREATH. ACUTE COUGH UPPER RESPIRATORY INFECTION, EXCERBATION OF ASTHMA, UNSPECIFIED ASTHMA SEVERITY. GIVEN AZITHROMYCIN, BENZONATE, BROMPHENIRAMINE - PSEUDOEPHEDRIN - DM, IPATROPIUM - ALBUTEROL, METHYLPREDNISOLONE - CONT. W/INHALER. REFERRED TO LUNG SPECIALIST. 4/4/23 - DR, MF FCCP - CHEST X-RAY, BLOOD WORK, ALPHA-I BLOOD WORK TO RULE OF COPD. NEXT APPT. APRN - EOSIOPHILS WAS 10 - SHOULD BE - LESS THAN 3. GAVE ME A FASENRA SHOT IMMEDIATELY, START BREZTR, INHALER. PHAR. WOULD NOT COVER ME RECEIVING THIS SHOT. AUGUST - FINALLY APPROVED NUCALA 100/ML AUTO-INJECTOR. THRU 12/31/2023 - VERY, VERY COSTLY CO-PAY UP TO $1300 - COULD NOT AFFORD. A LADY HELPED ME APPLY FOR PATIENT ASSISTANCE PROGRAM. APPROVED FOR NUCAL THRU 12/31/2023
This is a spontaneous report from a contactable consumer, the patient. A 26-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: ER2613), via an unspecified route of administration in the left arm on 18Mar2021 at 13:00 as a single dose for COVID-19 immunisation. The patient had no allergies to medications, food or other products. No medical history was reported. Concomitant medication included Emtricitabine ,Tenofovir Alafenamide (DESCOVY), Vitamin D, amphetamine salts (within two weeks of vaccination) for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 17:00, patient had flushed face which was more severe on left side (same side as vaccine shot). The clinical outcome of flushed face was not recovered.   No follow-up attempts are needed. No further information is expected.
1 Week after shot I devoloped a knot the size of a quarter  at shot site  with several bruises around knot.
Broke out with shingles on my right side of the torso. Underarms, chest and back. Lasted for a week after starting valtrex 1gm three times daily for 7 days
breakthrough shingles after both doses /Suspected vaccination failure; patient had a breakthrough shingles; This case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's comment: The reporter stated that an immunocompromised patient had a breakthrough shingles case and was already vaccinated with both doses of Shingrix. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Missed Miscarriage discovered at routine pregnancy ultrasound on 4/6/2021 (12 weeks 5 days pregnant) Deceased fetus measured at 9 weeks 5 days  D&C performed as a result on 4/7/2021 Estimated due date was 10/14/2021
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received an expired dose of the vaccine) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 024C21A) for COVID-19 immunization. No medical history reported. On May 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 13, 2021, patient administered expired product (patient received an expired dose of the vaccine). On May 13, 2021, administered expired product (patient received an expired dose of the vaccine) resolved. The reporter did not provide any causality assessments.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (2 months after getting the shot, my right arm started to hurt) and VACCINATION SITE MOVEMENT IMPAIRMENT (it still hurts when I lift it) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M70A and 007M20A) for COVID-19 vaccination.     Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Product Used For Unknown Indication, PIOGLITAZONE, ATENOLOL, METFORMIN and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced VACCINATION SITE PAIN (2 months after getting the shot, my right arm started to hurt). On 11-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (it still hurts when I lift it). The patient was treated with MENTHOL, METHYL SALICYLATE (BENGAY [MENTHOL;METHYL SALICYLATE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (2 months after getting the shot, my right arm started to hurt) and VACCINATION SITE MOVEMENT IMPAIRMENT (it still hurts when I lift it) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt received Fluad, instead of age appropriate dose of  Flu Quad. Pt was observed for 15 mins following vaccination. No adverse reactions, noted.  Left a message for Pt to call, to discuss med error. No response as of yet.
chills; feeling fatigue; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) reported that a male patient of unspecified age received BNT162B2 first dose on 24Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had his 1st dose of the Pfizer Covid-19 vaccine 18 days ago(24Mar2021) and is scheduled to return for his 2nd dose on 14Apr2021. He mentioned that after getting the 1st shot, at first he experienced no adverse events but later on he started to have chills and feeling fatigue. He wants to know if these are normal. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Had severe vomiting every half our from 3pm until midnight the day I received the vaccine. I was vaccinated at 10:30am. I couldn?t hold down any fluids and had severe lower back pain, fever and chills.
Patient began to feel tired, then began to have severe diarrhea, nausea, and dry heaves.  friday, 1/29/10 went to see her family physician who told her it was a reaction to the h1n1 flu vaccine, she was given a shot of phenergan to help with the nausea, patient was told to go to the ER if her symptoms worsened, but she did not need to go to the ER.
3/2/04 outdated Hep B #3 administered parents notified. Hep B #3 to be repeated at 12 months well child visit.
Information has been received from a mother concerning her 4 year old daughter with a milk allergy and a history of dental extraction who in approximately 1999 (at the age of 2 years old) was vaccinated with varicella vaccine. In approximately 2001 the pt developed a low grade fever after being exposed to chickenpox. The pt did not seek medical attention. Additional info has been requested.
After a couple of hours the patient had a red inflamed hand/arm. Went to the ER and after a dose of steroid and pain meds was fine. Again on 10/26 had chest pain and a CT scan was done to rule out a clot. Spinal tap was done and further neuro follow up is required
Red disc at eye of 50 cent piece pink for at 5-6" from there.
Reported pain in every joint in her body currently/every single joint in her body hurts; This is a spontaneous report from a contactable consumer reported for herself. This report is not related to a study or programme. A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on 29Apr2021 (at the age of 26-years-old) as DOSE 1, SINGLE for SARS-COV-2 immunization/ COVID-19 immunisation. The patient took COVID vaccine as she was planning to travel. The patient medical history and concomitant medications included none. The patient experienced reported pain in every joint in her body currently/every single joint in her body hurts on 29Apr2021 in the middle of the night. Patient got her first COVID vaccine the day before this report and overnight every single joint in her body started to hurt. She expected to have pain, but she didn't expect it to be this bad. The event every single joint in her body hurts was reported as worsened. Patient wanted to know if she could take pain killers and would this interact with the vaccine. Referred to HCP. Investigation assessment included none. Patient declined to provide details on height, weight, and primary hcp. Clinical outcome of event was ongoing and not recovered at the time of this report.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained. No further information is expected.
This reaction was immediate and I am concerned about taking the second dose. can I go to a medical facility to receive  my second shot.
Severe ache in shoulder of injection continuing more than 24 hours after injection, mild overall body fatigue continuing more than 24 hours after injection, off and on minor headaches continuing more than 24 hours after injection, foggy thoughts and inability to complete thoughts continuing more than 24 hours after injection, slight nausea starting about 24 hours after injection.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Lot number: EW0185), in left arm and on 22Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Phenothiazines, reaction(s): "Drug Allergy". 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: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient did not take other medication in 2 weeks.
Headache; Fever; panic attack after 12 years; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (panic attack after 12 years), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     The patient's past medical history included Herniated disc (on 26Mar2021 he had a stem cell treatment for his herniated disc on his back and cervical).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PANIC ATTACK (panic attack after 12 years) and CHILLS (Chills). On 30-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, PANIC ATTACK (panic attack after 12 years), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Non significant follow up received on 17-MAY-2021, no new information
Initial misuse report received from a nurse on 06 November 2013. The 4-months-old patient had received FLUZONE 0.25 ml intradermal (site not provided). Reporter stated that 0.25ml dose administered to a 4 month old patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Vax given 130PM - pale & limp from 530-645PM; nl exam @ 7PM.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 08-FEB-2017, the patient was vaccinated with an expired dose of VARIVAX injection, 1 dose, lot # L002869 with expiry date 27-JAN-2017 (route of administration was not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Serum sickness secondary to second Hepatitis B Vaccine (Recombinant) - (1st vax given 12FEB91 - 2nd given 12MAR91);