chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report from patient's mother refers to a 2 year old male patient. The patient was a premature baby. There was no history of drug allergies or reactions. On 02-JUL-2015 the patient was vaccinated with (Oka/Merck) VARIVAX lot # L006383 first dose, subcutaneous as routine vaccination. Concomitant medications were none. On 03-JUL-2015, within 24 hours of receiving the first dose of (Oka/Merck) VARIVAX, the patient experienced "itchy hive like rashes, that were red and swollen, big welts that sink in, turn into circle-like in area, with a clear center", that come and go all over his body. The hives started on his belly, moved to his upper back, bottom of his feet, near his eyes and ears. His ears were also swollen and red. He also experienced, within 24 hours of receiving (Oka/Merck) VARIVAX, difficulty breathing and was very pale. The patient sought medical attention and made an office visit and a visit to an unspecified urgent care center. The patient received BENADRYL as treatment in response to the events. The outcome of the events was reported was not resolved. Causality assessment was not provided. There was no product quality complaint involved. The lot check had been requested. Additional information has been requested.
Pt. had erythema 5.5 x 5 cm diameter with minimal pruritus that started the day after vaccine was given. Rash is now spreading to arm.
mild tongue swelling; tingling lips; This spontaneous case was reported by a nurse and describes the occurrence of SWOLLEN TONGUE (mild tongue swelling) and PARAESTHESIA ORAL (tingling lips) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced SWOLLEN TONGUE (mild tongue swelling) and PARAESTHESIA ORAL (tingling lips). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Adverse event, at a dose of 25 milligram once. At the time of the report, SWOLLEN TONGUE (mild tongue swelling) and PARAESTHESIA ORAL (tingling lips) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided.
Cellulitis localized to left upper extremity, itching, redness, increased warmth, tenderness.
High fever, 102+ Aches, chills  Tylenol treatment 500mg
Adverse Event- Blood Clots in left leg, pain and swelling Daily. Treatment-Eliquis blood thinner
This case was reported by a healthcare professional and described the occurrence of allergic reaction in a female subject thought to be aged between 60 and 69 years old who was vaccinated with influenza virus vaccine (flu vaccine, manufacturer unspecified). Concurrent medical conditions included iodine allergy. Previous vaccination included influenza virus vaccine given in 1999 (Wyeth vaccine), 2002 (Aventis vaccine), 2003 (Evans vaccine) and 2004 (Aventis vaccine). On an unspecified date the subject received a dose of flu vaccine (unknown). At an unspecified time after vaccination with this flu vaccine, the subject experienced swelling from the elbow to the shoulder. The swelling lasted for 3 weeks and then resolved. According to the subject, these events occurred on one or more occasions in the past following flu vaccination. The physician told the reporting nurse that he believed the events were due to the subject being allergic to the preservative in the flu vaccine. At the time of reporting the events were resolved. On 08 November 2006 the subject received flu vaccine (supposedly a GlaxoSmithKline vaccine) and experienced no reactions. On 19 June 2007, the subject received PNEUMOVAX and reacted such that the injection site got huge and red. The events were treated with ice at the injection site and they resolved after several days. According to information received, this event would have taken place after the reported reaction to flu vaccine documented in this case. Information received documented the following: The subject recorded a historical reaction of swelling for 3 weeks on her flu vaccine screening form completed 08 November 2006. Thus, the above reported swelling reaction had to have occurred sometime prior to 08 November 2006. Later that same day, 08 November 2006, despite a known history of previous reactions as recorded above, the subject was given and unknown brand of what was believed by the nurse to be a GlaxoSmithKline flu vaccine. No reactions to this vaccine were documented. No further information is available concerning this case.
Patient reports the night of the vaccine, she had chills and low grade fever (100.7F) that resolved by morning and she was tired for two days. On March 29, 2021, she had discomfort on the left axillary and left upper back areas which help like her "shirt was too tight and rubbing" and the upper back was like a "pinch" and she continues to have this. She developed a rash under her left arm on April 2 in the evening and it continued to spread and erupt across her upper back and chest. April 4, 2021, she developed blisters and it continued to spread down her left arm. She contacted her PCP and MD on  April 4, 2021. After describing the symptoms to MD, MD prescribed Acyclovir 800 mg PO 5 x daily x 10 days and gabapentin 300 mg PO TID. MD advised patient that she likely had herpes zoster. She reports she improved 40% with treatment and presented for evaluation 5 days after contacting MD and the diagnosis was confirmed.
Per office notes on 3/30/21 from APRN, CNP: About 5?10 minutes after receiving vaccination, patient developed itching to the posterior scalp area and to his lower back.  Patient brought back for evaluation.  Patient denied any sensations of swelling of the tongue or throat.  Denied any wheezing or stridor.  Only complaints were itching sensation. peripheral IV started and diphenhydramine 50 mg in addition to methylprednisolone 125 mg given intravenously.  Patient had clearing of the hives and red patches after medication administration.  Pruritus improved.
Night of vac - an injured ankle itched from ankle to knee all night. Next morning site of vac red size of quarter itching - leg ok - 3rd day headache off and on 3 day - never get headaches. Vac area size of half dollar - still itching 8 days.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site scab in a 67-year-old female patient who received SHINGRIX (batch number G45LN, expiry date 13th March 2021) and (batch number 5S34K, expiry date 13th March 2021) for prophylaxis. On 19th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. In November 2018, 7 days after receiving SHINGRIX, the patient experienced injection site scab, injection site extravasation, injection site abrasion and injection site exfoliation. On an unknown date, the outcome of the injection site scab, injection site extravasation, injection site abrasion and injection site exfoliation were not recovered/not resolved. It was unknown if the reporter considered the injection site scab, injection site extravasation, injection site abrasion and injection site exfoliation to be related to SHINGRIX. Additional details were provided as follows: The reported batch number for SHINGRIX adjuvant was 5F34K, which was changed to 5S34K, as per sales data sheet. About a week later after receiving SHINGRIX, the patient experienced that the injection site had dead skin that peeled off and now site of injection looks oozy and raw.
could not remember how to stand; would fall down when trying to walk /He was unsteady; would fall down when trying to walk; made no sense and could barely be understood; so sometimes he does not make sense.  Saturday it was exacerbated; peed the bed; This is a spontaneous report from a contactable consumer reporting for 4 patients. This is Report 1 of 4 for reporter's brother-in-law.  A 69 years old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on16Apr2021 10:00. Relevant history included Parkinson's with associated dementia, which comes and goes.  Relevant concomitant drugs included oxybutynin for bladderwhich had been taking for at least over a year, 'ropinirole' for parkinsons, and modafinil 100 mg for focusing; to help her brother-in-laws brain focus. The reporter stated the patient (her brother-in-law) only had the vaccine on Friday (16Apr2021).  He could not remember how to stand, would fall down when trying to walk, peed the bed: callers husband got her brother-in-law up and when he would walk, he would fall down.  They got him up and down to go downstairs to breakfast and have coffee.  He was unsteady.  All of this occurred on 17Apr2021 when they went to wake him up in the morning.  The patient also peed the bed.  The patient just does not always make sense.  On Saturday, he did not make sense.  Sunday, he was better and almost everything was back to normal. He was fine on 19Apr2021; he was himself. The reporter stated that the patient (her brother-in-law) has dementia anyways, so sometimes he does not make sense.  Saturday it was exacerbated, he would ask what to do next or where the bathroom is and this is all stuff that he knows. The patient still had his appetite, the reporter and her husband always say that when her brother-in-law can not eat or does not ask for food then the end is near. The reporter stated the drug Modafinal worked wonderful, he was great on Friday, and he was wonderful before he got the shot. Relevant test was none. The outcome of event made no sense and could barely be understood was resolved. The outcome of other events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
5days p/vax pt devel wide spread urticaria. treated w/susphrine & recommended benadryl
none, Patient had 3 shots of primary series and accidently received bivalent age appropirate booster dose.
Itchy Sensation - Near Injection Site; Hives - Near Injection Site; This spontaneous case was reported by a health care professional and describes the occurrence of PRURITUS (Itchy Sensation - Near Injection Site) and URTICARIA (Hives - Near Injection Site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (Itchy Sensation - Near Injection Site) and URTICARIA (Hives - Near Injection Site). On 25-Jan-2021, PRURITUS (Itchy Sensation - Near Injection Site) and URTICARIA (Hives - Near Injection Site) 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.  Steroids were reported as treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow-up received on 19-APR-2021 contains no new information. On 25-Apr-2021: Follow-up received on 25-APR-2021 contains no new information.
Breathing issues, unable to get a deep breath, back pains, had to use a walker for 2 weeks.
Stomach pain/abdominal pain started on March 4th, black stool started March 3rd (only lasted 4 days after the vaccine)-currently normal as of march 23rd and the patient states stomach pain is almost normal but not 100%, just an uncomfortable full feeling Patient didn't do anything and didn't see a PCP
Sore arm; Muscle pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and muscle pain. On an unknown date, the outcome of the pain in arm and muscle pain were unknown.   It was unknown if the reporter considered the pain in arm and muscle pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the consumer for one of the receptionist at the outpatient clinic. The age at vaccination was not reported. The patient had sore arms and muscle pain with the vaccine. He did not have the patient identifiers. Caller did not provide his doctor's address on the phone. This case has been linked with case US2019087036, US2019AMR088911, and US2019AMR088873 reported by the same reporter
Extreme fatigue sarting about 5 days after vaccination - requiring mid day naps (during work) and 2 hour earlier bedtime. Lasted approximately 2 weeks. Bilateral large axillary lymph nodes (2 cm, started about 10 days after vaccine, lasted about 2 weeks, interfered with resting arms at side),. Slight pain/discomfort in bilateral forearms (not sure if swollen) which interfered with ability to hold heavy items or do activity like pour coffee from a full pot hold laundry basket, sometimes had trouble using door handles  (felt like a compartment syndrome); Started about 2 weeks after vaccination and lasted about 3 weeks) . Slight pain in left shoulder with reaching (ie rotation of shoulder capsule) . started about 3 weeks after vaccination, maintained at that level for 4 months and then very quickly progressed to a confirmed diagnosis of frozen shoulder. Pain and significant reduction in range of motion of left shoulder - including inability to put bra on and difficulty dressing.  Two months later still receiving physical therapy 3x weekly with significant improvement in range of motion, but still having difficulty putting bra on and still have pain interfering with sleep.  Feeling of irregular heart beat, confirmed as frequent PVCs on monitor. Started 2 months after vaccination, ongoing. Not related to caffeine, alcohol, stress, time of day.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information about medical history, concurrent conditions and concomitant medication use was provided. In 2012, the patient was inoculated with the zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) as prescribed and/or administered by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX), the patient had and would continue 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 outcome of the event was reported as not recovered/not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Redness, swelling, warm to touch around injection site. Trmt: ibuprofen and cold compress.
This spontaneous report as received from a registered nurse to a 52 years old female patient who on 26-SEP-2012 was administered intramuscularly a dose of PNEUMOVAX23 (lot #H010515). Secondary suspect vaccination included a dose of Influenza Virus Vaccine (manufacturer unknown) (lot number not provided) on 26-SEP-2012. In 2012 the patient developed swelling at the injection site and a fever of 102F, which was not controlled by ADVIL at home. The patient was evaluated at an emergency room and treated for the swelling. No further details were noted on the after. The outcome of the events was unknown. The relatedness for the events and PNEUMOVAX23 was unknown. This is one of several reports from the same source. Additional information has been requested.
CLIENT PASSED OUT IMMEDIATLEY AFTER INJECTION PALE DIAPHORETIC 20 MINS LATER SAT UP SLOWLY BUT STILL FELT FAINT B.P 124/84 PULSE 88 TOOK SIPS OF WATER HAD HER LIE BACK DOWN CLIENT SAT UP SLOWLY AGAIN AT 2:26PM COLOR STARTED TO RETURN AT 2:35 CLIENT STATED SHE FELT MUCH BETTER BUT STILL NAUSEOUS STATED HAD LUNCH AND FLUIDS AT NOON TIME CONTINUED TO GIVE SIPS OF WATER BP 120/80 PULSE 84 WHEN FELT FRESH AIR NAUSEA DISAPPEARED LEFT FEELING BETTER AT 2:45 PM STAFF PREVENTED ANY INJURY STATED SHE FAINTS EVERYTIME SHE GETS A SHOT BUT DIDNT NOTIFY STAFF UNTILL AFTER INJECTION WAS GIVEN CLIENT WAS ADVISED TO NOT TO RECIEVE ANY FURTHER VACCINATIONS FROM OUR CLINIC BUT TO SEE HER PRIMARY CARE PHYSICIAN
Case number PHEH2015US017451, is an initial spontaneous report received from a physician via phone on 03 Sep 2015. This report refers to a patient of unknown age and gender. Medical history and concomitant medication was not reported. Physician reported that the pharmacist administered an expired FLUVIRIN (batch number: unknown) to the patient on an unknown date. No adverse event was reported. No further information was provided.
In 5/00 and 11/14/00, the vaccinee received her 1st and 2nd left deltoid doses of Lymerix, respectively. Approx. on 11/21/00, the pt experienced neck pain (middle of neck to left side). Approx. 11/28/00, the pt experienced headache with pressure in the right eye, which has resolved. On 12/11/00, the pt experienced joint pain in the knees and wrists, blurred vision, pain when opening her eyes, night sweats, mood swings, and a dry cough. She denied shortness of breath. As of 12/12/00, the outcome of the headache with pressure in the right eye is resolved. The outcome of the neck pain, joint pain in the knees and wrists, blurred vision, pain when opening her eyes, night sweats, mood swings, and dry cough is unknown.   Follow up on 03/06/2001: "The vaccinee was seen by her family physician.  He told her that "you had the flu and did not have a reaction to the vaccine (LYMErix).  As of 02/26/2001, the outcome of the headache with pressure in the right eye is resolved.  Additional information will not be available."
been in the hospital with the flu; Initial information received from on 17-Nov-2022 regarding an unsolicited valid  serious case received from a patient.  This case involves a patient of unknown age and gender who had been in the hospital with the flu after receiving Influenza Vaccine .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, route, formulation, administration site, lot number and expiry date unknown) for Influenza immunization.  The patient reported that he had been in the hospital with the flu since Tuesday 3:00am (influenza) (latency: 1 month) following the administration of Influenza Vaccine.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness Criteria : Hospitalization for the event; Sender's Comments: Sanofi company comment dated 08-Nov-2022:  This case involves a patient of unknown age and gender who had been in the hospital with the flu after receiving vaccine Influenza Vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Headache, Myalgia, left arm swelling & pain, chills, low grade fever Narrative: Called PMD, awaiting call back.
Dtap site developed moderately severe abscess subcutaneously, responding to antibiotic.
Erythema, edema, induration and tenderness at area of DTaP injection at 24hrs after vaccine - 2.5 x 3.5 inches. Started on hydroxyzine plus ice pack. At 48 hrs worsening symptoms - given ROCEPHIN IM.
Pt received Tenivac vaccine instead of Prevnar 20 vaccine. No adverse reactions noted at time of administration. Pt notified via telephone 30 min following, denied adverse reaction.
On the day of the vaccine, right after getting the booster shot from one of the clinics, I felt a cold feeling running down my arm with a tingling feeling in my fingers. I told the man who had given me the shot and he told me to go see my primary doctor. I had both shots before and was fine. So, I thought I was going to see how I feel. I was sick for about two weeks and then felt better. However, the pain in my shoulder where I got the shot never left and has spread. There is a pain every time I move the arm.  At times my arms feel weak, and like I cannot lift anything with that hand.  It has been about months since I got the injection and the site is still sore.
I began to experience a tingling on the upper right side of my lip. This resulted in  a swollen lip which extends up to my right nostril.
Patient was here for his 1st moderna vaccination.  After 5min of receiving the vaccine patient fainted and began to seize.  He came to after a few minutes, looked very pale.
Patient here for Dose #3.  Previous two doses were Moderna. Today, third dose administered was Pfizer.
stiff neck; This is a spontaneous report from a contactable consumer or other non hcp. An elderly female (age: 73; unit: unknown) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing (has a history of arthritis and has had to have steroid shots in the back). The patient experienced stiff neck on an unspecified date. She states that she's has developed a stiff neck, and has a history of arthritis and has had to have steroid shots in the back. She went to the ER and her doctor suggested getting cortisone shots in her neck. She wants to know if it will affect the efficacy of the vaccine. The outcome for event was unknown.   Follow-up attempts are completed. No further information is expected.
Excruciating arm pain near injection site for 10 weeks. Unable to lift arm.  Attempted to treat with predazone and  diclofenac. Temporary relief.
Information has been received from the mother of a female who was vaccinated with the second dose of Gardasil. Subsequently the patient experienced pain. The mother reported that her daughter will receive the third vaccination "late". Additional information has been requested. It was also reported that another daughter was vaccinated with Gardasil and experienced pain (WAES 0703USA03939).
Extreme joint pain, extreme swelling of joint at extremities,  extreme anxiety, began on 04/04/2021 and is still manifesting, although swelling and joint pain has dissipated to just forearms, both shoulders, wrists and both hands.  Very severe pain in both hips.  Ultimately, after full exam at Hospital ER on 05/08/2021, and subsequent exams by doctor of record, I was referred to a rheumatologist, who diagnosed me with Polymyalgia Rhuematica.  This autoimmune disease has never before been detected in my system by any physician.