chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administration error - Patient was administered the Janssen vaccine inadvertently when the intended vaccine (Pfizer/BioNTech) was meant to be administered due to their age (17 Years old). This occurred at a mass vaccination clinic where both brands of vaccine were being administered; the patient had gotten into the incorrect line and ended up being getting immunized at a Janssen vaccination station. No harm noted to the patient and there were no issues during the observation period.
Moderna COVID-19 Vaccine EUA Around 3am on 2/3/21  had nausea, body aches, headache, fluctuating body temperature (fever unknown). Pain at injection site started a few hours after administration and increased in severity, but still mild as of now 2/4/21. Noticed swelling at injection site sometime 2/3/21.  Nausea subsided late morning/early afternoon 2/3/21, with headache, body aches, fluctuating body temperature lasting until approximately 12am 2/4/21. No medical treatment was sought, no otc medications taken, only rested.
Overnight woke to flu like symptoms with violent shaking, fever, chills,  weakness, fatigue for about 7 days followed by lymph node swelling. Treated at Emergency Dept.
Delayed reaction; red area; firm underneath; sensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction), ERYTHEMA (red area), VACCINATION SITE INDURATION (firm underneath) and HYPERSENSITIVITY (sensitivity reaction) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction), ERYTHEMA (red area), VACCINATION SITE INDURATION (firm underneath) and HYPERSENSITIVITY (sensitivity reaction). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed reaction), ERYTHEMA (red area), VACCINATION SITE INDURATION (firm underneath) and HYPERSENSITIVITY (sensitivity reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
experiencing a very sore lump; sore also; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (experiencing a very sore lump) and VACCINATION SITE PAIN (sore also) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced SKIN MASS (experiencing a very sore lump) and VACCINATION SITE PAIN (sore also). At the time of the report, SKIN MASS (experiencing a very sore lump) and VACCINATION SITE PAIN (sore also) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications, Lab data details and Treatment information, if any, not provided.   Reporter did not allow further contact
Patient describes feeling flushes of heat on his face and upper body; fatigue; felt eyes having heat;
This spontaneous report was received from a consumer and refers to "beyond 26 years of age" female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. The reporter stated that on an unknown date the patient (her girlfriend) who was beyond 26 years of age was vaccinated with GARDASIL (route of administration, lot number were not reported). There were no adverse effects reported. The reporter stated that she was beyond 26 years of age and she was also interested in receiving GARDASIL and wanted to localize the healthcare providers who could administer this product. Additional information is not expected because the reporter did not provide the contact details.
Felt faint @ 10:05. Palms sweaty. Nausea. Headache. Took student to a mat to lie down. Improved. Refused water. 10:20 escorted back to classroom.
Her left arm where she received all 3 shots was sore all three times; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Her left arm where she received all 3 shots was sore all three times) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. TT2643) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia rheumatica (PMR), Autoimmune disorder NOS (Autoimmune condition) and Back disorder (Has always had lower back problems).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Her left arm where she received all 3 shots was sore all three times). At the time of the report, VACCINATION SITE PAIN (Her left arm where she received all 3 shots was sore all three times) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment medication was not provided.   This case was linked to MOD-2021-306253, MOD-2021-306205 (Patient Link).
Information has been received from a physician, via a company representative, referring to two unspecified patients of unknown patients of unknown age and gender. The patients' medical history, concomitant condition and concomitant medications were unknown. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (strength, dose, route, lot# and expiration date were not reported). The reporting physician stated that while on RECOMBIVAX HB, the patients did not seroconvert. The patients did not seek medical attention. At the time of reporting, the patients were not recovered from the event. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of white blood cell count low in a 69-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden for prophylaxis. On 30th October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On 12th November 2018, 13 days after receiving SHINGRIX and unknown after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced white blood cell count low. On an unknown date, the outcome of the white blood cell count low was unknown. It was unknown if the reporter considered the white blood cell count low to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional information was reported as follows: The patient was vaccinated with the dose of SHINGRIX on the left deltoid. On Monday, 12th November 2018, the patient carried out a blood work that showed that her white blood cell count was low (2.0). The patient had a follow-up appointment with her physician. Consent to follow-up was provided. The contact details of physician was provided. The vaccination date was unclear, it could be 16th October 2018 or 30th October 2018. Clarification was requested for the same.
Started with pain at site, then fatigue, dizziness. Extreme headache for 24 hours -  Bodyaches, joint pain, nausea, diarrhea
pt recv vax 5JUL95 & 6JUL95 pt exp sore throat, lymph node swelling & had fever & chills; pt was fine for approx 2 wk; then devel swelling in arms & legs; pt exp terrible lethargy, & sore throat & lymph node swelling persisted;
Redness & swelling at injection site x 3 days. Joint pain, myalgia from head to toe, fatigue x 2 weeks.
Initial report received from a healthcare professional on 08 May 2014. A 16-year-old female patient had received a dose of TYPHIM, (batch number, dose number, route and site of vaccination not reported) on 07 May 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. On 07 May 2014, same day after vaccination, the patient's throat was sore, swollen and had brown and yellow stripes in the back of the throat. The patient reported not feeling well the last few days before injection with throat soreness. Laboratory details were not reported. The patient received BENADRYL as treatment. At the time of this report, the outcome was unknown. Documents held by sender: none. Follow up information received from the healthcare professional on 30 June 2014. A 17-years-old patient had received an intramuscular dose of 0.5 ml of TYPHIM vaccine (batch number: J1631-1 and expiry date: 26 October 2015) in the left deltoid. On an unspecified date the patient was recovered.
She received the bi-valent booster vaccine as her first covid vaccine, had no previous primary doses
Patient was given a 0.25 mL of Moderna Bivalent Booster dose on 9/15/2022.The information was presented to the staff on 9/27/22. The patient was called on 9/28/22. Patient made aware received a  0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress at this time. Patient denied having to go to the Emergency room or Primary Care provider. Informed the patient according to Moderna the recommendation was to re vaccinat with full dose in 8 weeks from 9/15/2022. Patient stated would like to be re vaccinate. Patient made aware will reach out to patient regarding receiving full vaccination. Patient verbalized understanding. Patient encouraged to reach out to primary care
Numbness in arm. Inability to perform daily tasks (i.e...hold dental mirror,etc). Pain in wrist and elbow.
Eruption of herpes symptoms.  Herpes had been dormant for 15 years.
After my second COVID-19 diagnosis, I was feeling crappy, I had a high fever of 103, I was in bed a lot. I was very tired for a while. I had trouble walking and catching my breath. I had lower back pain. I'm not sure if it was remnants of the first time in 2020, I had long COVID-19. I had a lot of headaches. My pharmacist told me that my doctor put me on PAXLOVID, but I needed to reduce dosage because of my kidney function. So, I went to my doctor for an appointment eventually and I had her test my kidney function. The first test 08/09 I had a CKD of 49 then the second test was on 08/15 the numbers were a little bit better my CKD was 52. That's all that I have right now for my kidney issues. I am now seeing a Nephrologist.
Tightness in chest, coughing, mild difficulty breathing, lump in throat approximately 6.5 hours after immunization.  Called employee health nurse line, nurse said to call 911 and take a benadryl, but I did not comply as I did not feel like this was life threatening, opting instead to take two (2) 25mg Benadryl.  Symptoms resolved in approximately 1 hour following Benadryl.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient did not experience temperature excursion previously. On 21-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (dose and route were unknown, lot #: K050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case as one of several cases received from the same reporter. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 03/08, Pfizer, dose #2 08/09 pt cc: Cough and bodyaches exposure: unknown 08/12 COVID swab, result: detected 08/12 pt admit ED dx: COVID-19 infection LOC 1 day 08/12 SARS-COV-2 LINEAGE AY .3 08/12 SARS-COV-2 CLADE 21A DELTA 08/12 CXR impression: Heart is not enlarged. Minimal linear basal opacities probable atelectasis. Faint groundglass nodular density in left lower lung could be overlapping shadow artifact and/or indeterminate nodule, correlate clinically with CT for better evaluation with given history is indicated.
On 3/16/01 at 19:30, mother noticed left thigh was swollen, red and hot. No fever. Child didn't demonstrate discomfort. Very active  and didn't complain of leg pain. Was taken to ER because clinic was closed. ARNP saw client. Mother states the swelling was approx. 10cm. He was Rx'd antibiotic for 10 days. On 3/17/01, much improved next AM.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Seizure-Mild, Additional Details: Patient received vaccine (2nd dose) on left arm, felt dizzy while waiting in the observation area. Suddenly peed himself, and walked away. When we talked to him afterwards, he reports he thinks he might have had a seizure. Patient did not fall, said he had no history of seizure in the past. Patient declined to be sent to the ER or urgent care. Unsure exactly if it was a seizure or not. He said he did not have any reaction when he got his first dose.
Elevated temperature up to 102 F. Pt felt like he was going to pass out and was a little nauseous.
staff inadvertently drew and gave 12 doses (.2ml)  from vial instead of only 10 doses.  Per health department dose did not need to be repeated and patient not notified. Steps taken and protocol revised to prevent repeat occurrences. In addition to the patient mentioned, 1 other patient also received a dose from this (one of two sibling, not sure which patient received it)
Both patients (twin brothers) were given the pfizer bivalent (gray cap) instead of the pediatric version. They are 11 years and 3 months but not old enough to receive this vaccine yet. Upon speaking to the mother the following day, the patients both are doing fine and not experiencing any side effects from their vaccination.
gallbladder attack; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She got the first dose of the vaccine on Wednesday (20Jan2021) and she got a gallbladder attack afterwards (unspecified date in Jan2021). She wanted to report this and also wanted to know if there had been reports about this before. She said that she was not given an appointment for the second dose and wanted to know if Pfizer could help her with that. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Difficulty staying awake; Muscle and joint pain especially in the legs and back; Muscle and joint pain especially in the legs and back; Nausea; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 29Jun2021 at 16:45 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to food, medications, or other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Jun2021 at 07:00, the patient experienced muscle and joint pain especially in the legs and back, nausea, chills, fatigue, and difficulty staying awake. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events difficulty staying awake, muscle pain and joint pain especially in the legs and back, nausea, chills, and fatigue were not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow-up.
COVID vaccine breakthrough case. Pfizer 1/21/21 EL3249, 2/11/21 EL9267 and boosted 9/30/21 301358A and 4/14/21 FM9895
Wed. night noticed lymph nodes under L arm swollen and tender. Thurs. was achy, chilled and fever of 100.4. Friday felt normal. Sun. night noticed a red spot on her L bicep the size of an egg. Not warm to touch or having any red streaks.
Headache, Nausea Vomiting,  Fatigue, Lightheaded, Pain/swelling/redness at injection site  Narrative:
Redness and swelling at injection site, noted around 1800 on 1/10/14. Pt treated with oral BENADRYL and prednisolone 15mg/5ml 6ml po qd x3days.
1. Pain and numbness from hands to shoulder of left arm 10 minutes after injection; numbness lasted for @ 6 hours. Pain lasted for 3.5 days. On a scale of 1-10 (10 being the most), pain level in arm was consistently at a level 7. 2. Fatigue beginning  18 hours after injection and lasted for 3 days. 3. Chills beginning 10-12 hours after injection and lasted for 2 days.
Employee came to me 30 min (approx0 after influenza vaccine given, she was pale, clammy and shaky. She stated she was dizzy and nauseated. Had her sit down, placed cool wash cloth over forehead , blew into paper baby . Lasted approximately 30-45 min. Full recovery.
Fever started 6/9/05 evening; rash appeared 6/14/05.
I received the first vaccine 1/11/2021 and the second dose  on 02/03/2021. On  02/16/2021 my hair fell out in clumps.  I am post COVID and was Dx on 07/14/2020. I was discharged from the hospital on 09/17/2021.  From my stay in the hospital on 07/14/2020  up until 02/15/2021 I had the minimum hair loss that  one would loss in a day. I am not sure if the vaccines caused it , but my hair literally came out in clumps.  I also started experiencing heart palpitations  along with SOB in the evenings after the first vaccine.  Upon  the second week in February, I started experiencing the palpitations and SOB in the evenings. Again, I am not sure if the vaccines caused this as I am post COVID.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 02-OCT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes, on 25-SEP-2013 for 45 minutes, on 26-SEP-2013 for 2 hours and 30 minutes and on 01-OCT-2013 for 4 hours. No known adverse effects. This case is linked to case: 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, and 1310USA008407 (same reporter linked). Additional information has been requested.
Received vaccine at 11:30 on 1/15,  at 5:30pm developed itchiness from head to toe, took 25mg of Benadryl 1/15 at 9:30pm developed hives on back, stomach, hips and upper thighs,, hands were swollen took 25mg of Benadryl 1/16 at 3am took another 25mg Benadryl hives and itching. 1/16 630am took 25mg Benadryl and Claritin hives and itching improving. 1/16 at 9am all but 2 hives resolved to oatmeal bath and applied hydrocortisone. 1/16 at 630pm felt throat was swelling, voice change, tingling lips and thick tongue took 50 mg of Benadryl went to ER around 730pm. Was given Pepcid and 50mg prednisone in the Emergency Room. 1/16 11pm.Discharged home with prescriptions for prednisone, Benadryl and epi-pen and Pepcid.  Continues now with lingering sore throat
Patient felt weak, lost balance, became pale, eyes rolled around, pulse and blood pressure went decreased. With rest, a drink, and a snack patient started felling much better.
patient received expired vaccine on 4/4/21. it had expired on 3/31/22. no adverse reactions noted at this time.
Vaccine was shaken up before vaccine was given; A spontaneous report was received from a consumer concerning a 78 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) vaccine was shaken up before vaccine was given (product administration error).  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On unknown date, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly] for prophylaxis of COVID-19 infection.   On an unspecified date the vaccine was shaken before vaccine was given (product administration error).   Action taken with mRNA-1273 in response to the event was not provided.  The event product administration error was unknown.; Reporter's Comments: This case concerns a 78-year-old male who experienced nonserious unexpected event of Product administration error for mRNA-1273, lot # unknown, with no associated adverse events. Event outcome not reported.
ongoing hot flashes; Sweating; anxiety; mood swings; Weakness; swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 27Aug2021 at 09:15 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, von willebrand disease, chronic gastritis, polycystic ovarian syndrome (PCOS). The patient was allergic to penicillin, fish, strawberries and peanuts. The patient did not receive any medication within two weeks of vaccination. The patient previously took ibuprofen (MOTRIN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Aug2021 at 06:00, the patient had ongoing hot flashes, sweating, anxiety, mood swings, weakness and swollen lymph nodes. The hot flashes would not go away. She had never experienced this before the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events ongoing hot flashes, sweating, anxiety, mood swings, weakness and swollen lymph nodes was not recovered at the time of this report.
Within 3 hours Sore arm,  Within 24 hours chills, fever, nausea, body aches, extreme fatigue Ongoing