chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her arm is killing her; The vaccine that she received looked orange brown in the syringe; The vaccine that she received looked orange brown in the syringe/ saw vial which had pink cap and said 12 years and up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm is killing her), POOR QUALITY PRODUCT ADMINISTERED (The vaccine that she received looked orange brown in the syringe) and PRODUCT COLOUR ISSUE (The vaccine that she received looked orange brown in the syringe/ saw vial which had pink cap and said 12 years and up) in a 37-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included COVID-19 (Yes, tested positive for COVID-19) in January 2022.    On 28-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Jul-2022, the patient experienced PAIN IN EXTREMITY (Her arm is killing her), POOR QUALITY PRODUCT ADMINISTERED (The vaccine that she received looked orange brown in the syringe) and PRODUCT COLOUR ISSUE (The vaccine that she received looked orange brown in the syringe/ saw vial which had pink cap and said 12 years and up). At the time of the report, PAIN IN EXTREMITY (Her arm is killing her), POOR QUALITY PRODUCT ADMINISTERED (The vaccine that she received looked orange brown in the syringe) and PRODUCT COLOUR ISSUE (The vaccine that she received looked orange brown in the syringe/ saw vial which had pink cap and said 12 years and up) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  Patient stated that before vaccination she saw the vial which had a pink cap and said 12 years and up. The Pharmacist filled up the syringe and kept pushing back the syringe. Then pharmacist administrated the vaccine. Patient started getting suspicious because her arm was killing her. The caller explained that she wanted to know what was injected to her, but did not want to start a commotion.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2022: Follow up received contains QE number updated.
Vaccine hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a 65-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (In 2019 had shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK receipt date : 26-Aug-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received shingle vaccine and the vaccine hurt for 5 days since he/she was 65 years old The patient stated that in 2019 he/she suffered very painful disease lasted more than 6 months he /she got it on top of his/her belly button reaching up to the back of his/her spine on the right side that was a horrible fire Additional Supportive information: The duration  of event was 5 days. In 2022 Patient received shingle vaccine.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. On an unspecified date in 2011, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention of shingles and zoster-related injuries. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was unknown. As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The event shingles was considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.
Woke up next morning with transient dizziness x2 (05:00 and 06:30). Subsided after a few minutes.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The reporter stated that ROTATEQ was improperly stored and administered (dose, units, anatomical location, route of administration, lot number were not reported) to unspecified number of patients on unspecified dates. Additional information has been requested.
Developed sore arm, with sl. fever, diaphoresis, and difficulty moving arm.  Now has a red rash about 2 inches below vaccine administration site, which gets more red with exercise.
For both doses my joints and lower lumbar region hurt about 15 minutes after I got the vaccine.
Patient received H1N1 vaccine at 0915. Around 920a she began to experience mild chest pain and tightness, mild shortness of breath and mild dizziness.
Large, swollen redness around injection site 1 day after admin. Pt. given 3 vaccines, all in the same arm per his & parents request. Parents say he had had previous imm. reactions. But they are unsure as to when.
Apparent SIDS. (Pt had Hep-B/SKB/ENG5208A2/RL/0 on 7/26/01). Autopsy findings confirm cause of death to be SIDS.
Information has been received from a 58 year old female consumer concerning herself. The patient was allergic to neomycin (reported as "Neomyacin"). The patient's medical history included stomach removal and chickenpox in high school. She had family problems with shingles and her cousin lost eyesight in one eye. On 09-MAY-2016, the patient was vaccinated with ZOSTAVAX (lot# and expiration date unspecified), 1 injection. Concomitant therapies included thyroid medication levothyroxine sodium (manufacturer unknown), unspecified medication for her stomach and "lanadine" nose drops. On approximately 11-MAY-2016 (reported as two days after receiving vaccine), the patient experienced redness, pain, itching, swelling, hard lump, warmth and bruising where the shot was given. On the same day she also developed headache, had a red blot about the size of baseball, skin feels prickly, and had temperature of 100-101 Fahrenheit (F) degrees for a week. Unspecified treatment was given for the events. At the reporting time, the patient did not have recover from the events. The reporter did not provide the causality assessment between the events and ZOSTAVAX. Additional information is not expected as the contact detail was not provided.
About 10 minutes after the vaccine, the patient was standing in front of the pharmacy with his mom and fainted.  He landed on his buttocks and did not appear to hit his head.  He immediately appeared conscious but disoriented.  He had a steady pulse and no itching or rash or trouble breathing, but he seemed pale.  EMT was called and upon evaluation determined that he did not need further treatment.  The patient went home with his mother.
Admit 6/20, vaccine 4/7, 4/29. Admit for SOB - COVID PNA, severe sepsis, acute renal failure. H/O heart transplant and on dual immunosuppression. Remained on room air. Steroids not needed per MD. Tfer for further transplant care 6/22.
This spontaneous report as received from a pharmacist refers to a 37 years old female patient with idiopathic thrombocytopenic purpura and a platelet condition and with no drug reaction/allergy. The patient was vaccinated SC on left deltoid with the first dose, 0.5 ml VARIVAX on 26-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. In 2012 the patient developed shingles. No treatment information was reported. The patient had taken phone call for medical attention. The outcome of shingles was reported as recovering/resolving. Additional information is not expected.
Presented with CP, SOB, cough x2 days; diagnosed with COVID 19 PNA and acute hypoxemic respiratory failure. Tx:  Remdesivir, systemic steroids, supplemental O2 and lovenox. Is now on 2 LPM on O2 per NC.
While driving home in car, 1/2 hour after Influenza Vaccine given experienced hives of chest, back, inner thighs, and hands.
GBS, pt is apprehensive about other vx; This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-Feb-2022 Reporter's Comments: The reporter had a patient who developed GBS (Guillain Barre syndrome) after a dose of Shingrix within 42 days. The patient was due for a Flu shot and COVID-19 booster shot, but was apprehensive about receiving any more vaccinations. The reporter requested any information GlaxoSmithKline could provide. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR086239:same reporter, case deleted
Pt recv vax on 6/13/88 p/ lab test of failure to seroconvert (1st vax @ 9 mon of age);approx 4 wk p/ 2nd vax, in 7/88 pt exp inflammatory bowel disease; did not see Dr. until 11/1998 & underwent total colectomy.
Immediately I could taste a metallic salty taste in my throat. About 1 minute later my throat was burning and itching and I began coughing. The nurses put me in a room with another nurse, gave me cold water and watched me.  5 minutes later I began feeling dizzy and nauseated.  My throat seemed to settle a bit and I finally told them I felt good enough to leave about 45 minutes later.  Around 5 pm  my throat was still burning and throbbing, so I took a benedryl, claritin and a pecid. My head felt fuzzy.  I ate ice cream for dinner because my throat kept throbbing and I was still nauseated.  I went to bed at 6 PM and around 10 PM I woke up with my throat throbbing and burning and I ached all over as if I'd been beaten in my sleep.  I considered using my epi pen, but took another claritin and Hydrocondone instead because I never had trouble breathing and my lips didn't swell.  The worst was the swollen, itchy, throbbing throat and body aches.  By morning my throat had cleared up, but the body aches and headaches, and fuzzy headed are still with me 10 days later. I feel permanently damaged by the vaccine.
Pt recv vax on 4/13/99; 2 hr post vax pt exp red cheeks, swollen face, nasal congestion, itchy face
Feels sore and little swollen; Arm soreness and feeling crummy like does not feel good; Arm soreness and feeling crummy like does not feel good; Feels sore and little swollen; This is a spontaneous report from a Pfizer-sponsored program from a contactable Nurse (patient).  A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EK9231), on an unspecified date at single dose on arm for COVID-19 immunisation.  Medical history included asthma. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), took one puff twice a day and it's 100 over 50. The patient took the Covid vaccine. Her arm was feeling sore and she feels a little crummy after the vaccine like she feel crummy like she does not feel good. She wanted to know if she could take Tylenol because of her arm soreness and feeling crummy. It feels really sore and little swollen yeah. The outcome was unknown.
Temp 99.9, hypotonic, hyporesponsive episode lasting 48 hrs; duration 2 days still cranky, began thrush 17JAN91;
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 08-JUL-2014 the patient was vaccinated with an expired ZOSTAVAX, Expiration date: 21-JUN-2014 (dose, route and lot # were not reported). No adverse reactions reported. Additional information is not expected due to the pharmacist cannot be contacted again.
During the month of 12/2021 i developed tinnitus in both ears. It is a constant high-frequency sound.  As of 9/18/2022 the sound has not stopped.
pt recv vax;5-8 min later mom noticed blotches (red) appearing on abd & back;BP 100/60;unable to obtain;
No adverse effect; received improperly stored PEDVAXHIB; This spontaneous report was received from a nurse refers to a 4 month old male patient. The patient's medical history, concurrent conditions, historical drugs, drug reactions/ allergies and concomitant medications were not reported. On 09-SEP-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # S000353 and expiration date 09-OCT-2021 (strength, dose, frequency and route not reported) for prophylaxis (product storage error). Storage temperature was reported as above 47 degree Fahrenheit (F) (47.4 F) with timeframe of 23 hours. There was no previous temperature excursion. The call was made because of a data logger. No adverse effects reported. No product quality complaint (PQC) present.  This is one of three reports received from the same reporter.
Information has been received from a physician concerning a patient who was vaccinated with ROTATEQ vaccine, oral, (lot # not provided). The patient's stool samples was tested after receiving ROTATEQ vaccine and Rotavirus was detected. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 18-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 16-JUN-2017, the patient was vaccinated with a dose of improperly stored VAQTA injection (dose, route of administration were not reported; lot # N008823, expiration date 26-MAY-2018). The vaccine underwent a temperature excursion from 9 to 25 degrees Celsius which lasted 31 minutes and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected since all relevant data have been already obtained.; Sender's Comments: US-009507513-1708USA010049: US-009507513-1708USA010050: US-009507513-1706USA002146: US-009507513-1708USA010047:  US-009507513-1708USA010048:
Sore arm with some numbness. Treated with ibuprofen. Pain was minimized.
2JUN94 had a fever 100-101 for past 2-3 days; that day 12noon gave APAP-t102.5 (put in tub in tap water); took nap 15mins; checked temp again 103 R; (started staring upwards & stretching out (rigid); started looking purple & quit breathing
Patient died; This is a spontaneous report from a contactable consumer (parent's patient).  A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route on 13Feb2021 (at the age of 47-year-old) at single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 18Feb2021 the patient died. The cause of death was unknown. An autopsy was not performed. No COVID prior vaccination. The patient had not been tested for COVID post vaccination.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: Patient died
This is a spontaneous report from Non Clinical Study Program (Pfizer Customer Service) for a contactable nurse practitioner who reported for a patient. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date for infection. The patient medical history and concomitant medications were not reported. On 06Feb2015 the patient experienced injection site redness, injection site swelling, injection site pain/tenderness, injection site hives around the site to the skin/like hives around the skin, with outcome of not recovered. The patient underwent lab tests and procedures on an unspecified date which included full blood count, metabolic function test, red blood cell sedimentation rate, on results provided. The nurse mentioned that she saw the patient and the adverse reactions gone worst from onset date on 11Feb2015. Therapeutic measures were taken as a result of the events included prednisone, BENADRYL, ibuprofen and applied ice.
Blisters in mouth; This case was reported by a pharmacist via call center representative and described the occurrence of blistering of mouth in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number N99P3, expiry date 19th October 2021) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced blistering of mouth. On an unknown date, the outcome of the blistering of mouth was unknown.   It was unknown if the reporter considered the blistering of mouth to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced blisters in mouth. The reporter consented to follow up.
PATIENT FELT TO KILL HIMSELF; RETINAL DETACHMENT,  LOOSING VISION, BLINDNESS OF LEFT EYE; SORENESS/PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included bilateral cataract surgery a few years ago, and concurrent conditions included glaucoma, COPD (Chronic obstructive pulmonary disease), smoker (a little less than a pack a day), and alcohol user (about 1 drink a day). The patient had allergies to some of previous COPD medications (but the patient could not recall which).  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A31A, expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced soreness, pain at injection site after vaccination. On 13-APR-2021, 3-4 days after vaccination the patient started losing vision in his left eye. He visited his physician's office- primary care provider (PCP). He was referred to a specialist and was diagnosed with retinal detachment. It was reported that there was a slight vision improvement in his left eye since symptoms started. It was also reported that the patient was going blind from retinal detachment. The patient felt to kill himself (captured as suicidal thoughts), if he did not receive help for his condition. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from retinal detachment, loosing vision, blindness of left eye, and soreness/pain at injection site, and the outcome of patient felt to kill himself was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738594-Covid-19 vaccine ad26.cov2.s- Retinal detachment, Patient felt to kill himself. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Eyes swelled up; Vision blurry; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Apr2021 at 13:00 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity and asthma. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 15:00 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 04Apr2021, the patient's eyes were swelled up and made his vision blurry. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events eyes swelled up and vision blurry were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Dizzy. Weakened and could not stand- dropped to floor, nauseated. Cold compress to back of neck applied by spouse and anti- nausea pill. Ten minutes feeling better.