chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Shingrix for prophylaxis. On 8th September 2018 18:00, the patient received the 1st dose of Shingrix (subcutaneous). On 8th September 2018, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. In September 2018, the patient experienced injection site pain and injection site erythema. In September 2018, the outcome of the injection site erythema was recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix. Additional details were reported as follows: The reporter was a patient. The reporter stated that, she was administered a dose of Shingrix vaccine subcutaneously in right arm, which led to inappropriate route of administration. The pharmacist pinched a small area on the back of the arm and that was where the vaccine was administered. The patient experienced redness at the injection site which was 3 inches by 2 inches in area. The patient gave permission to contact her health care provider. No further details were provided. This case was link with case US2018165448 (fiancé's case), reported by the same reporter.
46 y.o. female with a history of ESRD, HTN, and DMII who was admitted due to dialysis access issues and planned surgery for permanent catheter placement.  She had COVID previously and has since had both doses of the COVID vaccine. Pre-op COVID test returned positive, but she remained asymptomatic during her stay. Surgery witout incident. Discharged.   46F with ESRD on HD who received the Moderna COVID vaccine on 1/29, 2/26 2021. Covid (+) on 3/19/2021, no other test results available. Asymptomatic.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 08-OCT-2014, an unspecified number of patients were vaccinated with improperly stored ROTATEQ lot # K001716, expiration date: 24-NOV-2015, oral (dose was not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician refers to 1 year old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On 26-APR-2016, the patient was vaccinated with VARIVAX (lot # L049536 expiry date 08-DEC-2017, dosage information not provided). Concomitant medication was not provided. On an unknown date in 2016, the patient experienced local cellulitis. On 07-MAY-2016, the patient was seen by the physician and the patient was treated with KEFLEX for local cellulitis. Since then patient's symptoms were resolved, on an unknown date. Causality assessment was not provided. Upon internal review "cellulitis" was determined to be medically significant. This is one of several cases received from the same source. Additional information has been requested.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 27-MAY-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (incorrect product storage) (lot # L030587, expiry date 10-FEB-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. It was reported that the PROQUAD was stored at a temperature of 4 degrees Centigrade between 06-OCT-2015 to 09-AUG-2016. It was reported that there was no previous temperature excursion. No adverse effects were reported. The action taken with the therapy with PROQUAD was unknown. The outcome of the events was unknown. There was no product quality complaint reported. This report was not because of a data logger. This is one of the many reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA011225: US-009507513-1612USA011226: US-009507513-1612USA011227.
Information has been received from a pharmacy student concerning an adult male patient who on 17-SEP-2009 was vaccinated with a dose of PREVNAR (manufacturer unknown) instead of a dose of PNEUMOVAX 23. Subsequently there were no adverse effects reported. All telephone attempts to obtain follow-up information have been unsuccessful. No further information is available.
Flushed face, had to clear throat a lot, cough, blood pressure high and short of breath, hard to breath.   They gave me Benadryl which only worked a short time.  Then got a shot of Epinephrine.
Information has been received from a physician concerning to his r 21 year old daughter with penicillin allergy and seasonal allergy who on 04-JUN-2008 was vaccinated with the third dose of GARDASIL vaccine (yeast) 0.5 ml intramuscular. The patient did not experienced any adverse event after the first and second dose of GARDASIL vaccine (yeast) (one of the two doses was given in November 2007). On 04-JUN-2008 the patient experienced low-grade fever and headache which lasted one day. On 07-JUN-2008, the patient experienced rash maculo-papular distributed on her face, chest and upper thighs and was slightly itchy. The patient was evaluated by a dermatologist and was prescribed topical steroids cream and course of oral steroids (name unspecified). The rash improved slightly at first but then increased to include the patient's shoulders and back. The patient was scheduled for another office visit with the dermatologist the week of 28-JUL-2008. The patient sought medical attention. Additional information has been requested.
patient got a double dose(1 cc) as his first dose of vaccine and reported no AE; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (patient got a double dose(1 cc) as his first dose of vaccine and reported no AE) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 21-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (patient got a double dose(1 cc) as his first dose of vaccine and reported no AE). At the time of the report, ACCIDENTAL OVERDOSE (patient got a double dose(1 cc) as his first dose of vaccine and reported no AE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided
This spontaneous report was received from a female patient of unknown age reporting on herself. No information was provided regarding the patient's medical, drug and allergy history or concurrent conditions. On 06-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 for prophylaxis (dose number, route, location of administration, lot number and expiration date were not reported). On 07-MAR-2018, the patient woke up with "pain, severe swelling, and redness at the injection site". She also reported that the area was "hot to touch". The area affected was from "the shoulder all the way down to the elbow". No treatment was given to treat the events. The outcome of the aforementioned events was not recovered. The causality assessment between the events and PNEUMOVAX 23 was not provided.
Reports pain and soreness in left shoulder and arm starting 1 day after injection. Then about 1 week later reports intermittent tingling  in  L arm and hand which is described as  lasting about 30 seconds at a time about 40 times per day.  Sought medical care on 3/29/21 due to ongoing "soreness" in shoulder and arm and the tingling.  At today's call client reports the shoulder and arm pain "better" but reports the tingling sensations continue.
Case number PHEH2014US001958, is an initial spontaneous report from a consumer received on 24 Jan 2014. This report refers to a male patient of unknown age. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309601) intramuscularly on 05 Jan 2014. Around 07 Jan 2014, 48 to 72 hours after vaccination, he was diagnosed with pityriasis lichenoides chronica (PLC). The outcome of the event was condition unchanged at the time of reporting. The seriousness and causality were not reported.
Per child's mom, night of vaccination date child spiked fever of 104.6 - 105.1 and acted lethargic. Called pediatrician who told mom that fever is expected after vaccination and to medicate with Tylenol and Motrin.  Mom stated that gave medication and cool baths but fever continued so she took child to pediatrician following day. Per mom, fever lasted 3 days following vaccination.  Discussed with doctor and decided to wait on vaccines until school-age. Child did receive Rotavirus vaccine on 7/27/12 with no reaction.
High fever began a little over a day after the shot, severe arm pain, approximately 4 days after arm began getting red and swollen, was diagnosed at clinic as cellulitis and KEFLEX 500 mg 4 x a day was prescribed and strarted improving.
2 days later the patient complained of major swelling of all cheeks and lips area; 2 days later the patient complained of major swelling of all cheeks and lips area; This is spontaneous report received from a HCP reporter. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation; hyaluronic acid, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that, 4 months later patient had COVID19 2nd vaccination, 2 days later the patient complained of major swelling of all cheeks and lips area. Patient started 40 mg prednisone for 5 days and fexofenadine for 7 days. Patient symptoms have improved. Update that HCP feels event is not device related. Symptoms on going. The outcome of the events was resolving.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt recvd vax 245PM; slept for 2 hrs p/vax; woke up t105 R x 2 hrs; uncontrollable crying for 2 hrs; took pt to hosp ER; given Motrin & instructed to cont giving APAP w/Motrin;
Pt received Pfizer x2.  Pt tested COVID + on 9/26/21 and admitted to hospital for COVID and N/V/abd pain on 10/3/2021. Pt has not received dexamethasone or remdesivir as pt on RA
Noticed swelling, redness, itching of (L) arm the day after vaccines given. Continued to get red and swollen into the second day. On exam extensive area of swelling redness with edema demarcation on (L) arm. ? cellulitis vs local vaccine reaction. Treated with ZITHROMAX 200 mg/5cc 4cc p.o. x 1, then 2cc p.o. x 1 x 4 and ATARAX.
Every time he gets his Shingles vaccine, he gets a couple of month's relief from his PHN; This non-serious case was reported by a nurse via sales rep and described the occurrence of unexpected therapeutic effect in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gallbladder disease (surgeon diagnosed patient with gallbladder disease), shingles (Shingles and surgery both occurred years before he came into their practice/care) and gallbladder removal (had an unnecessary gallbladder removal at the original sight of his Shingles). Concurrent medical conditions included post herpetic neuralgia (the patient suffered for many years from significant postherpetic neuralgia-PHN) and pain. Concomitant products included gabapentin and valaciclovir hydrochloride (Valtrex).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: Every time he gets his Shingles vaccine, he gets a couple of month's relief from his PHN).  The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK Receipt Date: 05-OCT-2023 The reporter mentioned that every time patient got Shingles vaccine, he got a couple of month's relief from his PHN. The reporter did not mentioned whether he was referring to Shingrix. They asked how many times they thought he'd gotten the vaccine, however they did not track that in their office and recommended they spoke to the pharmacy. The patient took Gabapentin for pain and they experimented with Valtrex during flare ups. The patient would be barred from getting more than 2 shots both by the pharmacy and insurance. They discussed this at length with manager and local GSK Agent. They all agreed that this was not an adverse event. However, because it was an unexpected and/or unusual outcome, it should be reported Again, this was all the substantive information. The reporter consented to follow up.
intermittent chest pain; headache; Initial information was received on 22-Dec-2021 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 year old male patient who experienced intermittent chest pain and headache while receiving vaccines IPV (VERO) [IPOL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 20-Dec-2021, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6984AA with expiration date 18-Mar-2023 via intramuscular route in the left deltoid (unknown formulation) and a dose from 0.25 mL to 2 mL of suspect IPV (VERO) via intramuscular route in the left deltoid (with unknown formulation, lot number and expiration date) for prophylactic vaccination.  On 20-DEC-2021 the patient developed a non-serious event "intermittent chest pain" (chest pain) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of IPV (VERO). On 20-DEC-2021 the patient developed a non-serious event "headache" following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and following the administration of IPV (VERO).  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) and POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (intermittent chest pain and headache).  At time of reporting, the outcome was Unknown for the event intermittent chest pain and was Unknown for the event headache.
patient had a reaction to after administration of vaccine; Initial information was received on 21-Apr-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves female patient who had a reaction to after administration of vaccine, while she received vaccines TETANUS TOXOID and HEPATITIS B VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID (produced by unknown manufacturer) and a dose of suspect HEPATITIS B VACCINE (not produced by Sanofi Pasteur) [lot number and expiry date not reported] via an unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, patient had a non-serious reaction after administration of vaccine (vaccination complication) (unknown latency) following the administration of TETANUS TOXOID and HEPATITIS B VACCINE.  It was reported that patient is in emergency department that had serious wound and needs Tetanus shot but she is refusing because she had previous reaction to one in 90s also, she had similar reaction to Hepatitis B vaccine which she received in 90s.   Details of laboratory data not reported.  Final diagnosis was patient had a reaction to after administration of vaccine.  It was not reported if the patient received any corrective treatment.  Patient was recovered with intensive care both the time of reaction corresponding to TETANUS TOXOID and HEPATITIS B VACCINE.
The patient visited the emergency room the day after vaccines were administered with complaints of shortness of breath, dizziness, high blood pressure, and a swollen arm (right arm).
Patient requested 1st dose of Moderna but did not mention they received J&J in March. She received 0.5mL dose of Moderna rather than the appropriate 0.25mL dose. Pt complained of no reactions or adverse effect from this vaccine.
Information has been received from a pharmacist referring to a 65 year old female patient with drug allergies to codeine and tramadol hydrochloride. No concurrent or historical conditions were reported. On 21-APR-2015 the patient was vaccinated with ZOSTAVAX subcutaneously (strength and dose unknown, lot # K023621, expiration date: 19-FEB-2015). There the patient did not take any concomitant medication. On 22-APR-2015, the patient experienced injection site reaction to ZOSTAVAX. The patient noticed injection site tenderness and redness. The patient initiated the use of hydrocortisone as treatment but the pharmacist advised her to stop. The pharmacist saw the patient on 30-APR-2015 and noted the redness had faded to a "pinkish color" and reduced in size to "about the size of a half dollar" at the injection site. The outcome of the events were recovering. Additional information has been requested.
PT WAS GIVEN "BOOSTER" DOSE OF PFIZER UNDER THE AGE OF 16.
Patient was waiting in waiting area after receiving Jenssen vaccine. After about 15 minutes, another patient who also received Jenssen came to inform me that her friend was having difficulty swallowing.  Patient was not able to speak English so her fried translated to her. She was able to talk and responding to her friend's questions. I gave her Benadryl liquid to see if it resolves. After 5 minutes or so she complained of having chest tightness and having hard time breathing. I immediately gave her EpiPen 0.3mg injection in left thigh.  After few minutes patient said he is feeling better with chest tightness but still having feeling of throat closing. at this time, I had one of my tech call 911 and provided another EpiPen injection (about 5 minutes after the first one).  Police showed up in approximately 5 minutes.  EMT showed up 10 minutes after them.  Patient was conscious the entire time. When EMT took her, she was feeling better but still complaining of difficulty swallowing. Management was informed about the incident
pt came in to get her 2nd shingrix dose. upon talking to her I realized she had gotten 3 doses total already and was about to get her 4th.
This spontaneous report as received from a physician refers to a 13 year old patient of unknown gender. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. On 14-AUG-2017, the patient was vaccinated with improperly stored GARDASIL 9 lot # M040412, expiry date 30-JUN-2019 (dose, route of administration were not provided). Data logger was not involved. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA007325: US-009507513-1709USA012766: US-009507513-1709USA012764.
Patient was exiting vaccination area when became faint.  Mom attempted to place in chair, I assisted Mom in placing patient safely on the floor.  Patient never lost consciousness, able to articulate in complete sentences with no difficulty.  Patient remained in recumbant position x  5 minutes, then sitting on bottom on floor x5 minutes, then standing to immediately sitting in chair x 5 minutes.  Upon standing, felt he had some fuzzy vision.  Mom relayed that the patient had not eaten breakfast this am.  Mom gave some peanut butter crackers and the patient felt much better.  PCO2 99%.  Pulse 86. Patient waited x 30 minutes post vaccination and left without further event.
not sure of outcome sore throat fever 99.swollen arm,. nasal congestion body aches
Intense throbbing pain in injection site.    Mild headache   Nervous/restless feeling all over
After my second dose I noticed the very next day my arms ,under arms and stomach and legs looks like mosquitoes bites all over and the itchiness was unbearable
The patient presented to the pharmacy to receive his Covid-19 vaccination. He was accompanied with his mother, who stated that she was there for support. It was not made clear to the vaccinator that the patient had a history of fainting with vaccines or blood draws. The vaccine was administered, and the patient immediately lost consciousness. The patient was placed in a chair with arms, and was caught before falling to the ground. The patient did not come in contact with the floor or any surfaces to cause further damage. The patient with quickly assessed by the pharmacist on duty and 911 was called by the other pharmacist. The patient quickly regained consciousness and was aware that he had "done it again". Neither the patient nor the mother were particularly concerned about the event, but we called the paramedics to be safe. The paramedics came and took vitals, everything checked out okay and the patient declined transport to the hospital. The patient's mother then drove the patient home.
Pt complained of dizziness in middle of night after receiving both a flu shot and a pneumonia shot.  Came in with a red tender axilairy area 2 days later and prescribed antiobiotic
Pt received vaccine on 10/10/13. Pt went thru drive thru on 10/24/13 stated she went home few hours after the vaccine, she felt like her throat swelled up and was difficult swallowing. She took a BENADRYL. After she said she got a flu.
Diarrhea; got a knot but on side of my brows and my hair; booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 (Lot number: 32030B1) at the age of 61 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose: 02, EN6404 PFIZER), administration date: 20Mar2021, when the patient was 60 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 01), for COVID-19 Immunization. The following information was reported IMMUNISATION (non-serious) with onset 05Dec2021, outcome unknown; DIARRHOEA (non-serious) with onset 06Dec2021, outcome unknown; HAIR DISORDER (non-serious) with onset 06Dec2021, outcome unknown. Therapeutic measures were not taken as a result of diarrhoea, hair disorder.  Additional information: Follow-up attempts are completed. No further information is expected.
redness, warmth, swelling itching over rt deltoid extending 3cm from inject site;
Fever 100.2, pruritic non-vesicular rash on arms, legs, face and stomach 24 hours after receiving.