chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client had an undisclosed dose of J&J on 03/09/2021 (LOT#1802072-LD) from pharmacy and shown up at Covid Vaccine center on 10/26/21 & 11/16/21, 04/20/21 for her Pfizer series and as stated per vaccinators' notes that client stated that she has no prior Covid vaccine as of 10/26/21. Thus, client was given the 1st (10/26/21) and 2nd (11/16/21) and Pfizer 1st booster dose(04/20/22) for Pfizer series per CDC guidance. Upon suspicion, on Pfizer 1st booster dose, vaccinator discovered via system, that client had an undisclosed prior dose of J&J on 03/09/21 as well and confirmed with client about this finding. Client consent to the discovered info and expressed understanding that the dose given on 11/16/21 was an error. Client did not experienced any adverse effect from neither of these doses given. Client consent to this VAERS reporting.
Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No concomitant medication were reported. No treatment medication were reported.  It was reported as unknown whether the patient used product or not until 04-Jan-2023.
This spontaneous report was received from a consumer concerning her daughter of an approximately 5 week old with no pertinent medical history and no drug reaction or allergies. On 05-FEB-2013, the patient was vaccinated with a dose of RECOMBIVAX HB (lot number and expiry date reported as H014132 and 08-FEB-2015 respectively, dose and route unspecified). There were no concomitant medications. On 05-FEB-2013 (within hours of vaccination), she noticed that the patient was having trouble sucking and feeding. She took the patient to the physician on an unknown date. No treatment was given. No diagnostic tests were performed. The outcome of trouble sucking and feeding was reported as not resolved as the patient was still having trouble sucking on breast, bottle and pacifier. The physician stated that he did not believe it to be related to RECOMBIVAX HB. Additional information has been requested.
Skin dark and warm spots on both hands.  Deep vein bursts. Several veins exploded on legs which later faded away. Hands dark spots still persist and continue to darken. A sensation of warmness to whole skin in the body especially the facial area. The sensation of warmth will come and go.  it does not last all day but when creams or other neutral products are applied on the skin, such as body lotion or body soap.
At approx 9:00 am RN administered PENTACEL to (L ) Vastus Lateralis IM, PREVNAR 13 IM (R) vastus lateralis & hep b IM (R) Vastus Lateralis approx 30 seconds after immunizations were administered infant broke out in erythematous symmetric red macule rash approx 1-2mm in size on anterior bilateral lower extremities below bilateral injection sites. Infant cried during shots & approx 1-2 min. after shots & then calmed down & no distress noted P-140, R-40, full & even, smiling at parents & responsive. Was seen by primary Dr 6/2/11 & stated that rash had faded. BENADRYL given & will f/u in 7 days & if further complications to go to ER.
Lymph nodes swollen; Injection area is swollen, itchy; Injection area is swollen, itchy; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Injection area is swollen, itchy) and VACCINATION SITE PRURITUS (Injection area is swollen, itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Injection area is swollen, itchy) and VACCINATION SITE PRURITUS (Injection area is swollen, itchy). At the time of the report, LYMPHADENOPATHY (Lymph nodes swollen), VACCINATION SITE SWELLING (Injection area is swollen, itchy) and VACCINATION SITE PRURITUS (Injection area is swollen, itchy) outcome was unknown.            No concomitant medicines were reported.  No treatment information were reported.
Hives - received Benadryl 50 mg and Epi-Pen
Flu symptoms 48 hours  Nausea 6 days Aggravated atopic dermatitis
Information has been received from a CMA concerning a 55 year old female who on 06/02/03 was vaccinated IM in the deltoid with a 0.5 dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M). On approximately 06/02/03 the pt developed soreness at the injection site, redness, swelling, and the anterior aspect of the arm had redness that radiated to the axilla area. She developed a fever of 101 and also complained of being tired and had pain in her hands and feet. On 06/04/03, the pt was seen in the physician's office and no treatment was required. No product quality complaint was involved. It was also reported that a 60 year old female was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (Lot # 644219/1079M) and developed soreness at the injection site, redness, swelling, and being tired (WAES #0306USA00519).  Additional information has been requested.
received only the liquid, DTaP-IPV portion of the PENTACEL product with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 15 months old male patient who had received only the liquid, DTAP-IPV portion of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] product with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine (Hepatitis A vaccine) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 30-Jun-2023, the patient received only the liquid, DTAP-IPV portion of a standard total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ840AA, expiry date: 16-Feb-2024) via intramuscular route in left leg for Immunization with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, Caller asks what's the medication or ingredient in the PENTACEL's vial (diluent) and powder? Another staff member, stated the reason they ask is because it was administered separately instead of together and to 2 different patients. Should they repeat the dose? Should they wait? Is there any harm in the patient receiving a partial or inactive dose?   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2023SA203212:01674842
After 24 hours, pt develop rash near chest and other parts of body-no sign of rash near area of injection.
Vaccine shot site is swollen and feels hard. Started to itch eight days after injection and there is a rash about 2" x 2" around the shot site.
Caregiver states patient has redness and swelling at injection site about 1.5 inches around. Complaining to be warm to the touch and sore. Denies any fever or itching at site.  Morning of 5/7/2020 gave loratadine as patient can't take benedryl with the other medications she is on, patient has been icing throughout the day with no spreading occurring. Provider advised  to continue monitoring , icing , and elevation. Evaluate for any spreading. Contact office if spreading  occurs any drainage, or pain worsens.
red spots/blotches on his ankles, hips, back, and chest; little red bumps come up; skin rash; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 as a single dose for COVID-19 immunization. Medical history included cancer sores and history of cancer, both from unspecified dates and unspecified if ongoing. Concomitant medications were not reported. On unspecified dates the patient experienced red spots/blotches on his ankles, hips, back, and chest, little red bumps come up and skin rash, all reported as non-serious. The patient called to state that he received the first dose of the Pfizer COVID-19 vaccine "about 2 and a half weeks ago" but did not remember the exact date. He stated that his next dose was on 05Feb2021. He called because he had an adverse event and wanted to know what to do. He stated that he had red spots/blotches on his ankles, hips, back, and chest which started after the vaccine was given. He stated he had a history of cancer. He reported that "I am fine except these little red bumps come up. I have no problem. I have these spots come up and they started down around my ankle and move onto my hips and I have few spots on the back but I do not know if the vaccine caused it or something else, so I thought I better report it anyhow." He stated that he had not experienced anything, "just this skin rash or whatever you want to call it". The patient then inquired if anyone else reported this before. He stated that he just wanted to know if this had anything to do with the COVID-19 vaccine or not. He also stated that "I do have a 'scan' doctor that takes care of cancer sores (further clarification was unknown) for me but I do not know (incomplete sentence)." The clinical outcomes of the events red spots/blotches on his ankles, hips, back, and chest, little red bumps come up and skin rash were all unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
normal fatigue; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT taken for asthma. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization, reaction(s): "normal fatigue", "headache". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "normal fatigue"; HEADACHE (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received vaccine at age 7 when vaccine recommended for ages 6 and under. No adverse reaction reported.
Headache; my blood pressure spiked very high 169/81; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (my blood pressure spiked very high 169/81) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (statins) and Allergy to antibiotic (Clindamycin). Concomitant products included LOSARTAN for Blood pressure high.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (my blood pressure spiked very high 169/81). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, BLOOD PRESSURE INCREASED (my blood pressure spiked very high 169/81) and HEADACHE (Headache) had resolved. Not provided.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 169/81 (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported. The action taken with mRNA-1273 with the event was considered as not applicable.    This case was linked to MOD-2021-261529 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received Contains significant information: Added medical history, Added concomitant medication, updated event onset date and outcome of the event  were updated.
Moved on June 2022. On 8/8/22 rec'd quadracel and vaqta. 24 hours after vaccination developed scleral icterus, loss of appetite, and lethargy. Seen in office on 8/10/22. Found to have scleral icterus. Labs drawn and shown elevated AST, ALT, and bilirubin. Hepatitis panel and G6PD drawn and were negative/normal. By 8/11/22 was clinically doing better. Eating and playing usual amounts. No medications had been given. 8/12/22 was seen in office and clinically was normal. Labs showed decreasing liver enzymes. Was admitted for asthma exacerbation on 8/22/22 for 24 hours.
Teen had 3 doses of non-approved doses of COVID vaccine. Bivalent booster recommended and parent desired. Prepared and administered incorrect, lower than approved product. Moderna 6m-5years  bivalent product was chosen in error. The dose amount was correct per age (0.5mL) but the product was erroneous and too low dose for teen. CDC was contacted for advice and CDC Clinical guidelines was referenced. Re-vaccination recommended and parent notified. Will take time with future preparation and remember the eight rights for safe medication administration.  No injury or ill effects reported.
Presented to clinic with rash (Bullous lesions) on trunk, legs, CBC done, started on antihistamines on 07/16/04-rash resolved on 7/20-Father phoned today 7/22 stated rash appearing and very itchy. CBC normal limits.
Information has been received from a registered nurse concerning a 18 year old female who was vaccinated with a second dose of Gardasil. Subsequently the patient fainted. The patient's outcome was unknown. No further information is available.
She was stable with her MS and then after the second shot after a period of time her symptoms worsened.
Arm was sore that night, by the next night she noticed small red bumps near injection site.  Patient came to the pharmacy 9/30/14 to report/show rash on upper arm.  It was approx 5x3", warm, red, slightly swollen and tender. She was given antibiotics by her dermatologist she saw earlier that day for unrelated reasons.
This report described the occurrence of failure to thrive in a female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. This report was received from the patient's mother and has not been verified by a physician or other healthcare professional. The patient's mother submitted a report directly to VAERS. The patient's medical history reportedly included a seizure following receipt of hepatitis B vaccine at 2 weeks of age. The mother stated that the neurologist explained the child was okay and the patient received a second dose of hepatitis B at a later time with no side effects. Other medical history, concurrent conditions, and concurrent medications were not reported. The patient received the first dose of Infanrix on 8/28/02. The mother stated that, two or three days post-immunization, the patient developed diarrhea. The diarrhea resolved after an unspecified period of time. The mother reported that the patient also experienced failure to thrive and decreased motor skills. The mother suspected that the vaccines the patient received contributed to the failure to thrive and decreased motor skills. She stated that the patient had been evaluated by several physicians, who would not provide any additional information as they do not feel this has anything to do with the vaccines given. However, the mother decided to stop all vaccinations at 4 months of age. The failure to thrive and decreased motor skills persisted as of 9/12/03. The failure to thrive and decreased motor skills in this report were considered to be medically serious (OMIC).
Pt arrived with a beat up vaccine card and asked for his second dose.  We prepared and gave Pfizer to him.  His dose was processed after he left the store.  It was then realized that he had received a Janssen vaccine on 5/3/21.  The phone number on the consent form is deactivated.  We have left a message on an alternative number to contact us.
herpes zoster related injuries; herpes zoster related injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or about 2016, the patient was administered zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) by unspecified healthcare provider at the physician's office, for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unknown date, the pt was treated by a physician, for the following injuries resulting from the pt's use of zoster vaccine live (ZOSTAVAX): herpes zoster related injuries. The outcome of herpes zoster related injuries was not reported. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
5/6/03: Pt received her chicken pox shot. It was administered after school. Dr's visit 4:15 PM. During her visit a TB shot was given. 5/9: I took the child back to the office to check her arm concerning the TB shot. All went well. May 11th and 12th: Pt complained of a stomachache. May 13: the school called that pt was sick. Dizziness and weak. She came home and went to bed for about 2 hours (fell asleep). She awoke with a severe headache and fever - her temperature was 103 degrees. Taken around 8:00 PM that evening to MD for an exam. MD spotted a few small pimples on her chest. The throat and ears were examined and declared fine. May 15: Pt taken back to MD. She was completely covered with pimples - her face, eyelids, hands (palms), feet, body, soles of her feet - everywhere the eyes behold. MD was puzzled. Her diagnosis was the vaccine or she was exposed to the chicken pox before she was given the inoculation. May 16: Pt was so sick that her throat was burning and sore. She cried all day and was not sleeping the night before. At 2 AM the 16th, we were all watching a sick child with fever and holding her throat. The decision was to take her to the ER. May 16 at 10:30 AM I made an appointment for her with MD. Her diagnosis was the child now had strep throat. She gave her: Omnicef capsules 300 mg 2 x a day and Hydroxyzine for itching. May 21: Pt is still covered with the marks, some of them are starting to heal and many others are blistering. She is very upset with her face and body. She rests and sleeps a great part of the day.
Lupus; autoimmune hepatitis; Information has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.   In or around 03-NOV-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX), for routine health maintenance and for its intended purpose of prevention of shingles (herpes zoster) (dose, route of administration, anatomical location, lot number and expiration date were not reported).   In approximately December 2016 (approximately one month after receiving the vaccine), the pt suffered and was diagnosed with lupus and autoimmune hepatitis. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The pt was looking for compensatory damages for past, present, and future damages, including but not limited to pain and suffering for severe and permanent personal injuries, health and medical care costs, lost wages, together with interest and costs as provided by law.   The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, lupus and autoimmune hepatitis were considered to be disabling and medically significant events.
The name of the  flu shot was FLUBLOCK. I don't know if it is Fluad or one of the other types nor who the manufacturer is. I also reported adverse reactions to the pharmacy. Symptoms: soreness at injection site for 4 days (normal for me) plus headache, nausea, sore muscles and fatigue. Symptoms lasted 4 days. Treated on day 3 with one extra strength TYLENOL tablet. NOTE: checked temperature multiple times and all were within normal range.
flu-like symptoms for 36 hours; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event flu-like symptoms for 36 hours.  The patient's medical history was not provided. Concomitant medications reported were unknown for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.   On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event flu-like symptoms for 36 hours.  No treatment information provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, flu-like symptoms for 36 hours was unknown.