chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTERED A VACCINE THAT WAS STORED AT 65 F FOR MORE THAT TWO HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced administered a vaccine that was stored at 65 f for more that two hours. On 15-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administered a vaccine that was stored at 65 f for more that two hours was not reported. This report was non-serious. The suspected product quality complaint has been confirmed to be the suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed. This report was associated with a product quality compliant : 90000182926.
Joint in left shoulder was incredibly painful for a month. Constant sharp pain especially when I moved it. Could hardly use my arm.
Pins and needles presented on left side of the face 24 hours after second Moderna vaccination.  48 hours after that, shingles developed on left side of face (covered area around the eye, on/in the nose, and upper lip as well across the cheek).  Shingles were accompanied by eye irritation, headaches (localized on left side), and light headness.  Treated with Prednisone and Valtrex.
This spontaneous report was received from a healthcare worker refers to a female patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. On an unknown date approximately in 2013 (about a year ago), the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular. The healthcare worker reported that the patient was currently in the office to receive her third dose of GARDASIL. No adverse effect reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Pt, approximately 18 years old, received a second dose of varicella virus vaccine live. Pt sought unspecified medical attention and found she had not seroconverted.
Extreme fatigue, flu like symptoms (aching bones), slight headache, nausea, loss of appetite, stiff neck
Apprehension, palpitations, BP 147/65, P 68, observed and d/c from medical.
Felt fine during the 15min waiting period, but once I got back to work started getting hot flashes but no temp and face went numb. still had smell and taste just felt like I went to the dental where they numb your face. Went to the ER because Nurse Advice Line said to. ER gave me Benadryl and that is all. Had symptoms for about two weeks.
Pt received PCV -7 (1st dose) on right leg on 5/7/03. Per mom, pt's injection site became red, swollen and inflamed 5/9/03 11 AM.  No other complications. Advised Mom to place warm compress to site for 5 minutes every hour, continue Tylenol PRN. Pt to return to clinic if condition worsens.
Had vaccine 1/13 10:40 am. Midnight 1/14, I woke up with chills, T 100, Nausea, fatigue, headache. This lasted about 24 hours-resolved some toward evening 1/14, woke up next morning feeling fine. Also very sore L arm at site. I just rested, took fluids and tylenol.
This spontaneous report was received via company representative from a physician who was also a 60 year old female patient referring to herself. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date in 2018, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose, strength and route of administration were not provided) for prophylaxis. The patient was 60 years old at the time of vaccination. No adverse event was reported.
Rash and urticaria of left arm at first then bilateral arms and legs. Truck and face spared.
Information has been received from a registered nurse concerning a 16 week old patient who on an unspecified date was vaccinated with a first dose of ROTATEQ vaccine live (human-bovine). It was noted that the office thought the patient had already received the 1st dose before 12 weeks of age, but he did not. It was noted that the patient was not experiencing any known symptoms. At the time of the report the patient's status was unknown. There were no product quality complaint involved. No further information is available.
Secondary transmission; bronchitis; fever; lymphadenopathy; tinnitus; sinusitis; rash; ostroarthritis - Information has been received from a 41 year old female physician, born 21 Jan 1953 with no known drug allergies and hypothyroidism whose sister was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation in early december 1994.  The sister experienced a low grad fever.  Lymphadenopathy and arthritis two to three weeks after the vaccination waes# 01033214.  The physician visited her sister during the third week post vaccination and felt that the vaccine virus may have been transmitted to her at that time.  Concomitant therapy included levothyroxine sodium (synthroid).  On 20 jan 1995 the physician experienced a low grade fever, macular rash, lymphadenopathy, sinusitis, bronchitis and diffuse arthritis, which was the worst in her right knee.  The sisusitis and bronchitis were treated with azithromycin (Zithromax).  The physician noted that most symptoms resolved within a month or two however, the arthritis pain continued and the following summer she developed tinnitus.  both the tinnitus and the arthritis continued to the present.  The physician had seen a rheumatologist and has since been diagnosed with osteoarthritis of the right knee, left elbow and lumbar sacral spine.  no further details were provided.  additional information has been requested. A 15-day follow up report received 4/19/2002 adds: Additional info from the physician indicated that she was reporting transmission of rubella from her vaccinated sister to her. Her sister developed lymphadenopathy, polyarthritis and low grade fever after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (WAES #01033214). The physician developed a fever to 103, lymphadenopathy, arthritis and bronchitis 3 weeks after contact with her vaccinated sister. She noted that she had severe rubella 01/23/1995 with a very high IgM for rubella. At the time of this report in May 2001, the physician still had post rubella arthritis of the right knee and severe tinnitus. She had recovered from the other events. The physician indicated that the arthritis and tinnitus were persistent disabilities/incapacities.  No further details were provided.
Fever, chills, headache then on 6/25 I broke out with 2 pustules on my lip and left ear lobe.
pt recvd vax 30AUG90 & lab eval revealed a low rubeola titer of .25 on 19MAY93; No further details were provided;
09:25: Toddler developed hives starting around injection site, progressing to shoulder and back.  To ER, hives developed on legs.  No breathing difficulties in clinic or ER. Given Benadryl and steroid shot states mom. Recommended Benadryl Elixir for 2 days if needed follow up with ER physician.  Telephone call 12/15/03, no further hives.
Pt was here for RN visit for flu vaccine; rec'd it without event and then, on way down in elevator, parents noted hives and brought her right back to clinic. Went in to see pt - she was in NAD, 100% O2 sat, sitting on mom's lap; OP clear, lungs CTA without wheezing and heart with RRR and no murmurs; no lip swelling; hives appreciated on neck and face but nowhere else. Per mom, pt doing well other than a recent URI which has resolved. No other concerns prior to flu vaccine. On review of record, pt did receive BENADRYL once before in clinic at last visit on 2/28/18 for pruritis and hives (no vaccines at that visit); per mom, no add'l doses given at home after that visit. BENADRYL 12.5 mg x 1 given in clinic. VS remained WNL (O2 sat always >98%) throughout 30+ minute observation and hives almost completely resolved and no additional sx occurred. Never any mucosal involvement or breathing difficulties - OP remained clear and nml lung exam. She remained in triage room coloring and interacting with parents. As hives had all but resolved, decision to discharge home with Rx for BENADRYL to be given Q6hrs as needed at home. Parents advised that if she develops any e/o anaphylaxis (lip swelling, difficulty breathing), that they are to call 911 and head to ED. Additionally, due to proximity to flu vaccine, referral placed to allergy for input and recs.
It was my 4th Pfizer shot (2nd booster) and it triggered a Pityriasis rosea outbreak.
each time I started with a strong headache and head pressure within 2 hours of the vaccine, and felt "off" for 24 hours (a little dizzy, a little nauseous, exhausted)
Several days after the booster shot I started getting migraines.  Within a period of 10 days I had approximately 8 migraines.  I was taking sumatriptan for them and that drug is not recommended more than 3 times per week.  It was recommended that I go onto anther drug  and the Dr. prescribed it but the insurance company refused to fill.   Shortly there after the migraines ended.  Then on January 1st I started experiencing COVID symptoms and tested negative on  1/3/2022 but positive on 1/8/2022.  I my symptoms got much worse on 1/7/2022 and then on 1/10 the Dr put me on Paxlovid.  I am still sick but starting to feel better.
45hrs later Moderna Arm  is developing; acute pain at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (45hrs later Moderna Arm  is developing) and INJECTION SITE PAIN (acute pain at the injection site) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (45hrs later Moderna Arm  is developing) and INJECTION SITE PAIN (acute pain at the injection site). At the time of the report, RASH (45hrs later Moderna Arm  is developing) and INJECTION SITE PAIN (acute pain at the injection site) outcome was unknown.            The patient reported after the 2nd dose of vaccine he experienced acute pain at the injection site, unlike any other vaccine. The patient reported that he has taken a lot of vaccines in the past.  The patient reported that it was his 2nd arm  now as recommended.   This case was linked to MOD-2021-067078, MOD-2021-067078 (Patient Link).   Reporter did not allow further contact
Woke up today with swelling of upper lip. No hx trauma. Previous episode 8/2011. * Received immuniz x 4 - 10/26/11. Also has ear infection - started antib 10/28/11.
pt. complained soreness, heaviness at the injection site 2 weeks after the vaccination, lasted several months.
After experiencing excruciating pain, especially every single night, patient went to doctors and learned she have Adhesive Capsulitis or Frozen Shoulder. Patient feels there is a possible connection between the Tdap vaccination (received on 8/25 in right shoulder area). Physical Therapy has been recommended and ordered.
From a needle puncture a wound has grown to the size of a silver dollar. It is round in shape with what appears to be a rash around the edge. No scab forms to heal the wound. Two and 1/2 months since the initial shot.
This spontaneous report as received from a Registered Nurse refers to a 72 year old female patient with no known drug reactions. On 07-OCT-2014 the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 (lot#, expiration date, dose not reported) intradermally instead of purified protein derivative (PPD) test. On 08-OCT-2014, the patient experienced site of administration was swollen, red and pain in her forearm around the injection site. The patient was prescribed an unspecified antibiotic for this reaction to the PNEUMOVAX 23 intradermally. The outcome of the events was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Patient states getting JandJ vaccine yesterday, was seen in the ED for same s/s except stating lost of taste and smell starting today. Denies contact with Covid-19
pt recv vax & 5 days post vax felt draggy, was not feeling good, was lethargic, had diarrhea, cramps, constipation & weight loss & did not want food;ER or MD visit was required;tx ATB;
Pt with dizziness and feeling drowsy, received benadryl. Sx progressed to chest tightness after about 30 minutes and pt felt that eyelids were heavy. VSS and EKG normal. Evaluated by EMS but declined transport to ED. Went home in stable condition with continued chest tightness.
The patient received 1st vaccine dose Saturday afternoon Mar 13.  On Wednesday Mar 17, about mid-day the patient complained of stomach pains believing it to be constipation.  We postponed our dinner, and she laid in bed the rest of the day.  Likely took some Bisacodyl laxative.  The following morning - having worsening pain and what looked like a distended abdomen, we contacted the local 911 to come bring her to the local community emergency room - mid morning.  After about 6 hours they called to tell me that my wife had an ischemic bowel and was being rushed to surgery which happened at about 7:00 pm.  Dr. (surgeon) called to say they removed the gangrenous part of her bowel, and would see on Saturday if the rest of the bowel pinked up.  Unfortunately it did not.  The patient is left with about 2 feet of small bowel, and an ileostomy.  Likely TPN for the remainder of her days.
Patient reports receiving Shingrix Vaccine Injection # 1 on 5/7/19. c/o redness and swelling to deltoid area and spreading down arm this AM. Taking Benadryl for allergic reaction without improvement. Denies itching. Area warm to touch. 6cm  wide over deltoid, 5 1/2 cm wide between bicep and triceps. 16 cm length from deltoid to mid upper arm. Red area marked for patient to monitor redness for improvement or worsening.
Itching; Redness; A spontaneous report was received from a consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching and redness around the site of injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced itching and redness around the site of injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, itching and redness around the site of injection was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
the patient had an unspecified test which was positive for HPV after being vaccinated for HPV; This spontaneous report was received from a physician assistant via field representative and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, drug reactions, allergies, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, dose number, lot #, expiration date and route of administration were not reported) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, dose number, lot #, expiration date and route of administration were not reported) for prophylaxis, it was unable to determinate which vaccine was given to the patient.  On an unspecified date, after human papillomavirus (HPV) vaccination, the patient had an unspecified test for human papillomavirus (HPV), and the result was positive. The outcome of the event was unknown. Causality assessment was not provided.
two hours after vaccine administration, lasting for approximately one hour, experienced feelings of a racing heartbeat, heaviness in chest, elevated temp and lightheadedness, and general not feeling right, then those symptoms began to subside and over approximately the next two days had the general side effects of sore arm and fatigue.
Severe flu-like symptoms; Nausea; Weakness in legs; Headache, as if her head was in a vise; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included COVID Vaccination and Mono Clonal Antibodies. Concurrent medical conditions included liver transplant.   On 28th December 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, lower extremities weakness of and headache. On an unknown date, the outcome of the influenza-like symptoms, nausea, lower extremities weakness of and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, nausea, lower extremities weakness of and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's Comments: The patient self-reported this case. The patients concomitant medications included Antirejection drugs (undefined). The patient received her fist dose of Shingrix and experienced severe flu like symptoms, nausea, weakness in legs, headache (described as if her head was in a vise). The patient could not recall when the symptoms started and how long they lasted. The reporter did not consent to follow-up. Reporter did not wish to consent for HCP follow-up. Reporter provided limited information. Additional Supportive Information: This case has been linked to US2022066912, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066912:Same reporter.
skin become purple color; Left wrist swollen upto all fingers knuckles/Skin is dark red in color and puffy; Skin is dark red in color; Swollen areas hurts on pressing; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Left wrist swollen upto all fingers knuckles/Skin is dark red in color and puffy), ERYTHEMA (Skin is dark red in color), PAIN IN EXTREMITY (Swollen areas hurts on pressing) and SKIN DISCOLOURATION (skin become purple color) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced JOINT SWELLING (Left wrist swollen upto all fingers knuckles/Skin is dark red in color and puffy), ERYTHEMA (Skin is dark red in color) and PAIN IN EXTREMITY (Swollen areas hurts on pressing). On 24-Mar-2021, the patient experienced SKIN DISCOLOURATION (skin become purple color). At the time of the report, JOINT SWELLING (Left wrist swollen upto all fingers knuckles/Skin is dark red in color and puffy), ERYTHEMA (Skin is dark red in color), PAIN IN EXTREMITY (Swollen areas hurts on pressing) and SKIN DISCOLOURATION (skin become purple color) outcome was unknown. Not Provided          no concomitant medications reported. no treatment details reported.
While nurse was administrating the vaccine, some of the vaccine leaked out from the space between the syringe and the needle.
booster; my left hand has severe pain, as well my left leg; my left hand has severe pain, as well my left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), administration date: Apr2021, for COVID-19 immunization, reaction(s): "my left arm went dead- could not raise my arm"; Bnt162b2 (dose: 2), administration date: Apr2021, for COVID-19 immunization, reaction(s): "my left arm was numb, and hurting"; Bnt162b2, administration date: Apr2021, for COVID-19 immunization, reaction(s): "sciatic vein had been irritated"; Bnt162b2 (Dose: 2), administration date: Apr2021, for COVID-19 immunization, reaction(s): "my arm was better-the pain in leg diminished, but did not disappear".  The following information was reported: Immunisation (non-serious) with onset nov2021, outcome "unknown", described as "booster"; pain in extremity (non-serious), pain in extremity (non-serious) all with onset nov2021, outcome "not recovered" and all described as "my left hand has severe pain, as well my left leg". the event "my left hand has severe pain, as well my left leg" was evaluated at the physician office visit. therapeutic measures were taken as a result of pain in extremity, pain in extremity.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Red rash around face, red swollen eye, lips swollen and started bleeding, crying uncontrollably. Eventually blisters appeared and skin peeling. Given diagnosis of Staphylococcus Scalded Skin syndrome. Required hospitalization for 3 days and given Clindomycin via IV and then orally for 10 days.
vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.
T 104, intermittent crying, irritable, wants to be held, doesn't want to walk. TX 3 doses of Panadol liq. 1 1/2 dropperfuls, ea dose, tepid bath, ice pack to leg.
8 days after the injection I acutely developed itching, redness, and induration of the injection site. Lasted 24 hours, spread slightly and then started to resolve.