chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  12/28/20 Pt seen in ED with c/o "my knee gout is acting up and my bursitis," pain attributed to chronic pain syndrome 12/31/20 COVID VACCINE DOSE #1 01/21/21 COVID VACCINE DOSE #2 02/03/21 Pain score = 1 02/18/21 Pain score = 0 02/25/21 Pain score = 10 -> 0 with no treatment, seen in ED for 'chest pain 10 out of 10 x 2 day, pain radiates left fingers/hand up to shoulder, neck, down into chest, back, right arm, continued pain/sore to buttocks, heartburn, continued left elbow bursitis;' later denied chest pain 03/05/21 Pain score = 8, seen in ED for 'feet tingling sensation that usually started prior to gout attack and right hip pain, ran out of colchicine, right hip pain that radiates towards right knee 07/23/21 Visit with provider and informed chronic opioids will be tapered, pt disagreed with recommendation 07/26/21 Pt reports adverse event (severe pain, starting in arm, then gout in his ankle and now his leg hurts and collapses when he walks) via hotline, but no previous mention in any record notes of an issue with the vaccine Current symptoms not likely a result of COVID vaccine based on lack of evidence in medical record of patient report of pain.
This spontaneous report was received from a nurse referring to a 67 year-old non-pregnant female patient. The patient's pertinent medical history and concomitant medications were not reported. The patient's drug reactions/allergies included allergy to ibuprofen(ADVIL) (patient gets double vision) and allergy to unspecified sulfa drugs (causes rash). The patient's concurrent conditions included allergy to latex (causes rash). On 31-JUL-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly, lot # N004564 with expiration date 22-OCT-2018, for prophylaxis. On the same date, the patient developed cellulitis of the left arm. It was sated that she got edema, pain, swelling, redness and increased temperature in the left arm. The patient went to the clinic and received treatment for the adverse event (not specified). At the time of reporting the outcome of cellulitis of the left arm was reported as recovering. A product quality complaint was not involved. The causality assessment between cellulitis of the left arm and PNEUMOVAX23 was not provided. Upon internal review cellulitis of the left arm was determined to be medically significant.
No adverse effect, administration error only. Received first dose of vaccine approximately 60 days after receiving monoclonal antibody treatment instead of the recommended 90 days.
w/in 20min p/vax pt began to exp itching, hives & swelling to inj site;applied ice pack & took DPH;scalp & arms began to itch;seen in ER given epi & 02;
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by a health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021 at 8:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-May-2021 at 8:22 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.98.  Concomitant products were not provided.  On 24-May-2021, Excursion time was 08 AM and 09 AM, temperature was 35 and 35, total doses given for the day was 39, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 03-May-2021, vial was moved to clinic on 24-May-2021. 1 vial was sent to clinic. Vaccine BUD date was 02-Jun-2021.  On 24-May-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 35, 10 AM: 42, 11 AM: 40, 12 AM: 40, 1PM: 39, 2 PM: 37, 3 PM: 37, 4 PM: 32.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Diarrhea/ Vomiting/ Abdominal pain/ Indigestion Lasted 11 days Advised pt. to take OTC Prilosec And stay hydrated.
6 hours after injection and lasted for over 72 hours: Chills  Body aches Tired severe bone pain severe joint pain in ankles, knees, hips, shoulders, elbows, wrists Right side swollen lymph nodes in neck, chest, and under arm Bullseye mark on R arm around injection site Right arm swelling severe arm pain unable to list arm Severe migraine weakness, unable to stand Dizziness Fainting/blacking out
At around 1pm following the vaccine, I became very nauseas. Originally, I attributed this to the food I?d eaten earlier in the day, but a friend who?d eaten the same food was fine. At about 2:30pm, the nausea became unbearable, so I rushed to the restroom and vomited multiple times. Shortly thereafter, the nausea passed. Later in the evening, beginning at around 7pm, I couldn?t move my left arm without extreme pain, like pain worse than the second-degree burns I got in March. It was so unbearable that I could not lift my arm higher than waist-level and had to take NyQuil and melatonin to sleep. It was searing pain in the muscles or my upper left arm, radiating out to my shoulder and wrist. When I awoke the next morning at around 6am, the pain was virtually gone, with only a minoring burning sensation when moving my arm.
Approximately 40 minutes after getting my second dose of the Pfizer vaccine I developed severe abdominal pain and chest tightness. I could not take in a deep breath and became diaphoretic with cold and hot sweats. My ring and pinky finger, both hands, became numb and were tingling with the numbness traveling down to my elbows. I became lethargic and had a feeling of extreme uneasiness followed by a bout of diarrhea.  I then fell asleep for approximately 2 and half hours without moving. When i woke up the numbness was gone but I was still fatigued and had intense abdominal pain and still having the feeling that something wasn't quite right. I went to the ED the following day for the pain and general feeling of being unwell. At the ED I had high blood pressure, tachycardia, large amounts of blood in my urine and high WBC in addition to the above symptoms. For approximately two weeks after the initial onset of symptoms I still had abdominal pain and distention and  extreme bloating.
Swelling at site of shot, considerable pain in shoulder, numbness in arm. Treated with Ibuprofen and warm compress. No change in symptoms as of four weeks later.
The client actually should have received the 2nd dose Moderna vaccine and was inadvertently given the 2nd dose as a Pfizer instead.
ER Visit on 4-26-2021  ER visit on 6-25-2021 Afib
Fatigue, chills, headache, shortness of breath, nausea, vomiting for 2 weeks duration
experienced itching on her upper torso after 2nd dose; This is a spontaneous report from a Pfizer-sponsored program  Support. A contactable consumer (patient herself) reported that a female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date as single dose for COVID-19 immunization. The patient experienced itching on her upper torso after 2nd dose on an unspecified date and wanted to know if she can take Benadryl. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
mom called today to report that pt had fever of 105 the evening of vax; 1 1/2 droppers of APAP was given every 4 hrs but temp remained high until 1AM; pt exp vomiting & diarrhea; on SEP17 rash appeared, had roseola; on 19SEP rash faded;
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 039D21A, 017B21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Drug was not specified). Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (VICKS DAYQUIL/NYQUIL) from 19-May-2022 to 20-May-2022, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), CALCIUM, ERGOCALCIFEROL (CALCIUM +D [CALCIUM;ERGOCALCIFEROL]), MULTIVITAMIN [VITAMINS NOS], PARACETAMOL (TYLENOL) and IBUPROFEN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient experienced recurrence of symptoms 7 days after finishing full course of Paxlovid. The patient was taking other medications within 2 weeks of COVID-19 treatment.  Company Comment: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 6 days and had COVID reinfection 7 days after treatment with Paxlovid. No other clinical or treatment details were given. The reported outcome of the event was unknwon. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious, adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the fourth dose of mRNA-1273 Vaccine. As reported, the patient was treated with Paxlovid for COVID-19 for 6 days and had COVID reinfection 7 days after treatment with Paxlovid. No other clinical or treatment details were given. The reported outcome of the event was unknwon. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
I developed chills, fever, achiness, and headache within 7.5 hours of the vaccine; these symptoms lasted around 20 hours . The  weakness and headache lasted another day or so.
Pt recvd HIB vax on 12MAR91; On 09APR91 parents noticed redness & a lump on the lt thigh; On 11APR91 there was a 1.5 x 1.5cm area w/mild redness; tx meds;
At dinner, she had a sudden onset of a "visual disturbance". "pulsating vision and very bright". She felt woozy and lied on the floor.  Her husband helped her up and to bed and she again felt woozy and fainted on the way to bed.  She went to bed and feels fine today.  She is not sure if it was the pneumonia vaccine.
Left arm sore for  about 9days. On 5/18/21, my right ringer started to swell at the joint, by 5/21/21 finger pain went thru hand and painful bumps started to appear on elbows and fingers. By 5/28/21 both hands were swollen and left foot. I had a follow-up appt with my doctor on 6/29/21 and by then both feet were swollen, both hands were swollen and the left knee.
indurated area around vaccination site Narrative: Developed quarter sized area of circular induration around injection site 2 days after vaccination. Described as erythematous, not pruritic. No hives, sloughing, warmth. No therapies tired or applied, no other adverse effects noted. Area resolve ~day 4 after vaccination.
Pt felt lightheaded and dizzy. Pt was brought into medical room. Laid onto stretcher and vs were taken . Bp was 142/103 and pt was allowed to rest for 15 mins. Pt symptoms kept persisting and bp went up. Pt spent an hour with no relief of symptoms. Pt wanted to get checked out at Hosp. 911 was called and pt wax placed on heart monitor at hospital. Iv ns was given  kvo at 500ml via 22g cath in lt wrist.  Pt was t/f to 911 stretcher and pt care was t/f to 911 wo incident .
dizzy; broke out into a sweat; feeling a little nauseous; chills; breast cancer stage 1/taking anastrozole; breast cancer stage 1/taking anastrozole; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ELV5318, expiry date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. Medical history included stage 3 kidney disease, breast cancer stage 1 and blood pressure abnormal (reported as 'blood pressure') all from an unknown date and all ongoing. Concomitant medication included anastrozole (manufacturer unknown) for breast cancer, levothyroxine (manufacturer unknown) for kidney disease and amlodipine (manufacturer unknown) for blood pressure. The patient has breast cancer stage 1 and was taking anastrozole. The patient got the vaccine on 30Jan2021 and did not have any side effects 22 hours later, on the day of the report, 31Jan2021. The patient was grocery shopping and became very dizzy and thought she has to keep this together. The patient then just broke out into a sweat and managed to get herself home. She was feeling a little nauseous and she got the chills and then it (unspecified) was pretty much over in about 2-3 hours. The patient was scheduled for the second dose on 20Feb2021. The patient did not receive any treatment for the events. The outcome of the events was unknown.
No Adverse event; monovalent vaccine for 6-11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6-11 years old administered instead of bivalent vaccine).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657547.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657547: US-MODERNATX, INC.-MOD-2022-657560:Same reporter
This spontaneous report as received from a physician via a company representative refers to a 2 month old female patient. The patient's medical history included low blood platelets. On 17-MAY-2013 the patient was vaccinated with ROTATEQ dose 1, 2 ml, oral, lot number and expiry date were not reported. On 17-MAY-2013, the patient experienced onset of diarrhea, the patient was brought to the emergency room and was admitted to the hospital for an unspecified amount of time. The patient was tested positive for rotavirus (hospitalization), diagnosis was by means of stool sample. Treatment information was not reported. The outcome of being positive for rotavirus is unknown. Causality assessment was not provided by the reporter. Additional information has been requested.
pt recv vax 1130AM 31JUL;6hr later pt noted gen body achiness, fever;fever 31JUL present mac T102;local tenderness;PE 2AUG97 11AM temp 100.4, inj site w/erythema & tenderness;
Rt OM 2 wks Ceclor (otitis prior to vax); & recurrent otitis since then; pneumonia, RSV, otitis 24FEB low grade temp & pullling lt ear to MD later today;
20 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (20 weeks pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (20 weeks pregnant). On 30-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (20 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Second dose Moderna inadvertently given on day 23 after first dose Moderna COVID-19 vaccine.
6 days of fever 101-104.5 degrees with onset of diffuse coarse maculo-papular rash (not on hands or feet)on day 3. Mild nasal congestion and very red throat, treated with Tylenol and Motrin.
Tested positive for Covid-19; Tested positive for Covid-19; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Nov2021 (Lot number: EW0217) at the age of 31 years as dose 3 (booster), single, administration date 13Mar2021 (Lot number: EN6207) as dose 2, single and administration date 19Feb2021 (Lot number: EL9266) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. No COVID prior vaccination. No known allergies. Concomitant medication(s) included: METHIMAZOLE. No other vaccine in four weeks. The following information was reported: IMMUNISATION (medically significant) with onset 04Nov2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Client came for her COVID Pfizer Pediatric dose #2. Vaccinating nurse vaccinated client on her left arm but when he injected the COVID Pfizer Pediatric dose #2, he noticed the liquid was flowing down client?s arm after he retracted the needle into the barrel (safety mechanism). Vaccinating nurse decided on his own to reinject client on the same left arm with a new needle of COVID Pfizer Pediatric dose 0.2 ml lot # FK5618 exp. 1.28.22 at 1630 on 12.14.21 and notified PHN afterward. Vaccinator told PHN after client left the EMT station with her mother. PHN notified Clinical Project Lead who told PHN to call client?s mother to check on child. PHN told vaccinator about PHN going to call the client?s mother to check on child. He requested to call client?s mother on PHN?s county phone. At 1718, he called client?s mother with PHN present who told him that child was doing well at home after they left the vaccination site, and he told client?s mother that client received the full dose of Pfizer Pediatric dose #2 of 0.2 ml. PHN told him to educate client?s mother on adverse reactions to COVID-19 vaccine and when to seek EMS. He said client?s mother verbalized understanding. PHN educated vaccinator to elevate any needle issue or needing to revaccinate any client to PHN lead in the future. Vaccinator verbalized understanding.
Loss of range of motion in arm that received 2nd injection. Worsening over time. Went to have my arm looked at last week due to increased pain. Evaluated by physician and now require physical therapy. Suspected "frozen shoulder" as a result of the needle being placed to close to my shoulder.
Headache, Myalgia, Arthralgia, Fever,  INJECTION SITE PAIN  Narrative:   Other Relevant History:
Swelling, redness, tenderness, pain, low-grade fever. Within 2 hours after injection, swelling and redness extended over right deltoid to 15.38 cm. Within 24 hrs. symptoms worsened extending down upper arm to anti-cubital fossa -26.9 cm. Self treated with ice x 24hrs, then cold and warm compress, Acetaminophen PO. Symptoms subsided in 5-6 days.
On 4/19, I was light headed, body ached, arm sore where injection was, had 100.7 temp.  It all subsided on 4/20.
Patient broke out in red, itchy rash taht started from area of injection left arm that spread to torso and belly. Patient took otc Benadryl to help with rash and itching. Went to primary doctor and was prescribed a Medrol dose pack.