chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received VZV and TDAP on 8/4/10-Pt into clinic on 8/17/10 c/o that she has felt "funny" after receiving vaccine. Pt state about 15/20 mins after receiving vaccine. Denies rash or fever. She had tingling feeling in arms/legs with some itching. Felt uncomfort on neck/throat area. Denies breathing difficulty/wheezing. States she is concern about getting additional vaccine. Still having some tingling. Inst. pt to try BENADRYL-today since it has been 2 wk since vaccine. If no improvement follow up with doctor.
Information has been received from a medical assistant referring to a 4 month old male patient. No relevant medical history or concurrent conditions were reported. On 01-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
Information has been received from a physician concerning a 9 week old male who on 27-NOV-2007 was vaccinated IM in the right vastus lateralis with one first dose of hepatitis A virus vaccine inactivated (lot # 654814/0804F). Concomitant vaccination included a first dose of Prevnar given IM in the left vastus lateralis and a first dose of Pediarix (lot # AC21B069AA) given IM in the left vastus lateralis. On 30-NOV-2006 the patient's mother reported that the patient developed a slight fever after the injections on 27-NOV-2006. Additional vaccination included a first dose of Recombivax HB (lot # 653301/0278F) given IM in the right vastus lateralis on 01-DEC-2006. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Rash behind left ear; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash behind left ear) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced RASH (Rash behind left ear). The patient was treated with HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Rash behind left ear) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included hydrocortisone.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: NNI
Shingles (started with severe headaches, then rash 2 days later and diagnosed on Friday 3 days later.  Treated with anti virals).
Patient reported violent shaking about 40 minutes after receiving high-dose flu vaccination at pharmacy. Patient was home with neighbors and did not seek medical treatment. Patient called pharmacy after resting and feeling better. Patient also then reported dry mouth and bad headache. No injection-site reaction was reported.
Information has been received from a medical assistant referring to a 6 month old female patient. No relevant medical history or concurrent conditions were reported. On 29-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
I received my flu shot at my school from a nurse on October 4th. The flu shot was given at the top of my right shoulder, instead of the upper arm. I immediately felt pain in my shoulder and have continued to feel pain since the shot was given. It is affecting the daily use of my arm. My range of motion is limited, there is stiffness, and sharp pain throughout the shoulder. I am not able to carry out daily activities that could easily be done before receiving the shot. I have tried taking over the counter medications, Icy Hot patches, and Meloxicam, none giving relief. I went to see my primary doctor on Oct.19th. I have tried to reach out to patient relations twice, with no response.
coughing; felt crappy; tired; Last night started coughing a little bit, then started coughing hard and started throwing up; This spontaneous case was reported by a consumer and describes the occurrence of COUGH ( coughing), MALAISE (felt crappy), FATIGUE (tired) and VOMITING (Last night started coughing a little bit, then started coughing hard and started throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 029K20A) for an unknown indication.     The patient's past medical history included Heart disorder and Clotting disorder. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA) and METOPROLOL for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced COUGH ( coughing), MALAISE (felt crappy), FATIGUE (tired) and VOMITING (Last night started coughing a little bit, then started coughing hard and started throwing up). At the time of the report, COUGH ( coughing), MALAISE (felt crappy), FATIGUE (tired) and VOMITING (Last night started coughing a little bit, then started coughing hard and started throwing up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature (102-Unknown): 102 102.         This case was linked to MOD-2021-073665 (E2B Linked Report).; Sender's Comments:  MOD-2021-073665:Linked to 1st dose
Headache, Myalgia, Arthralgia & Fever Narrative:  missed one day of work following second dose due to flu-like symptoms
This spontaneous report was received from the physician via Pfizer refers to a female patient of unknown age. The patient's medical history included prevnar 13 injection in 2015. The patient's concurrent conditions and concomitant therapy was not reported. On 12-JUN-2018, the patient was vaccinated with PNEUMOVAX 23 in the left deltoid (dosing details, route, lot # and expiration date were not reported) for prophylaxis. On 12-JUN-2018, the patient experienced cellulitis post injection (cellulitis) and on an unknown date in 2018, the patient experienced significant swelling at the injection site (injection site swelling). The patient was prescribed with bactrim DS 800/160mg every 12 hours as a treatment for the events, but it did not respond. On 16-JUN-2018, patient was hospitalized, and the patient's discharge date was unknown. The patient's sought medical attention. Outcome of cellulitis was reported as recovered completely and outcome of injection site swelling was unknown. The reporter considered cellulitis to be related to PNEUMOVAX 23 and the causality assessment for the event injection site swelling was not reported. Upon internal review the event of "cellulitis" was determined to be medically significant.
Acute vertigo and distorted vision for 12 days, followed by two weeks of lessening vertigo and distorted vision.
pt recvd vax & devel itching all over; pt was treated as an outpt w/Seldane as of 17SEP92 itching persists; sl itching recurred 14NOV92;
Red, rashy, itchy, irritated, lumpy arm one week AFTER vaccine was injected
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 13:00 as dose number unknown (booster), single (Lot number: GJ5342) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: CT contrast" (unspecified if ongoing); "Known allergies: iodine" (unspecified if ongoing); "Prostate cancer" (unspecified if ongoing); "HBP" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient treated with Paxlovid with start date as 30Mar2023 and stop date as 04Apr2023.
Quarter-sized erythema at injection site. Seen 2 days, post vax. At 1 day, with reports at central site was "hard under the skin", but resolved in 24 hours. No fever.
Two minutes after the participant got the vaccine, she began coughing and complaining of tightness of the throat and numbness and tingling on the face. She was then given 15mg of Benadryl intramuscular injection. She was monitored, but her symptoms didn't improve; even after 10 minutes, she still had tightness of the throat and numbness and tingling on the face. She then began having chills, shivering, nausea, vomiting, and overall weakness. 911 was called, and the paramedics came and transferred the participant to the ER. The staff were told that she was being sent to the Medical Center, but they aren't sure if that's the case.
Patient came to Pharmacy and states that approximately one week after receiving  booster dose of moderna she started presenting a generalized rash on all body. She went to the doctor and was prescribed  benadryl and methylprednisolone by oral route but she stated no improvement. She is now on atarax 25 mg to control itching. She will be requesting an appoinytment with an allergist since stated is not improving
Systemic: Body Aches Generalized-Severe, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Additional Details: She said it felt like how she did when she was diagnosed with COVID
Fever; Fatigue; Body Aches; This case was reported by a physician via call center representative and described the occurrence of fever in a 71-year-old patient who received Herpes zoster (Shingrix) (batch number XJ57B, expiry date unknown) for prophylaxis.   On 19th August 2019, the patient received the 1st dose of Shingrix. On 19th August 2019, less than a day after receiving Shingrix, the patient experienced fever, fatigue and general body pain. On an unknown date, the outcome of the fever, fatigue and general body pain were unknown.   It was unknown if the reporter considered the fever, fatigue and general body pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient that had fever, fatigue, and body aches after receiving the first dose of shingrix. The reporter did not consent to follow-up.
Four weeks after the booster shot a slight tremor began in bilateral upper extremities. Then other symptoms progressed including panic attacks, anxiety, numbness and tingling in hands.
like something stuck in throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (like something stuck in throat) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced OROPHARYNGEAL DISCOMFORT (like something stuck in throat). At the time of the report, OROPHARYNGEAL DISCOMFORT (like something stuck in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant Medications were Provided By the reporter. No Treatment History was provided by the reporter.
No adverse effect; Improperly stored vaccine administered; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUL-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (rHA)(oka-merck) virus vaccine live (PROQUAD) injection, lot # S003326, expiration date: 02-AUG-2020 (exact dose, site and route of administration were not reported) for prophylaxis. The vaccine experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius (-0.4 degrees Celsius) for 20 hours. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001776: US-009507513-1907USA010132:
After getting the 4th dose of the vaccine, I had a sore arm, and I was really tired for three days then I had a Breakthrough Case of COVID on May 15, 2022. On the 14, I had a real bad migraine, an the the I had a really bad sore throat, I never had a fever but I was a little warm, my eyes hurt and my head hurt really really bad. I had burning in my chest, almost like I had bronchitis but much worse .
Chills; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 (at the age of 57 years) at 14:00, as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and COVID-19. The patient was allergic to strawberries. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills and tiredness on 22Mar2021. The patient did not receive any treatment for the reported events. 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 chills and tiredness was resolving at the time of this report.   No follow-up attempts needed. No further information expected.
Numerous discrete, purpuric lesions noted on lower extremities no itch and burning. Assoc with ankle/knee swelling and pain. Pt had concomitant URI - afeb, no NAD, O2 Sat: 92, plus coarse rules.
Rash with hives. Given Benadryl and topical creme. Using Claritin OTC. No Breathing difficulties.
Demarcated rash with itchy, crusty pustuals around the elbow. Oral cavity problems including swelling of inner lip. She also reported puffy eyes, nasal congestion, and fatigue
Swollen, red, itchy, hot area at injection site one week after the shot Stabbing pain in lymph nodes in armpit on same side
On Saturday I ached from the top of my head to my toes. All over! Sunday I felt unsteady, light headed, and woozy. I took my O2 and BP and my O2 and BP were fine but my HR was 133 beats a minute. I checked it throughout the day and my heart rate was high off and on. I woke up the next day(Monday) and it was high heart rate again and I was light headed. Tuesday it happened again. As well as today (Wednesday). I can feel my heart beating and I am very lightheaded. Cardiologist said that he has several patients with similar complaints and said I should be ok 5-7 days from now.
heart attack; This is a spontaneous report from a contactable consumer (patient herself).  This 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration in the right arm, on 06Mar2021 at 15:30 (Lot number EN6203) as single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration in the left arm, on 27Mar2021 at 15:30 (Lot number EP7534) as single dose, for COVID-19 immunisation. Relevant medical history included allergy to nickel and latex). Past drug history included allergy to penicillin. Relevant concomitant medications included ezetimibe, chondroitin sulfate, glucosamine, biotin and vitamin (unspecified). No other vaccine was received in four weeks. The patient had a mild heart attack approximately two weeks after her first dose of the vaccine (untreated) in Mar2021 and a major heart attack 2 weeks to the day after her second dose (11Apr2021, at 02:00). The patient visited the emergency room and she was hospitalized for 5 days. The event was also considered serious as life-threatening. Therapeutic measures taken as result of the event includes angioplasty. The patient was recovering from the event.
no other AE details to report; expired Proquad administered to patient; This spontaneous report was received via company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 04-AUG-2020, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) lot # R030799, expiration date 22-APR-2022 (dose and route of administration were not reported), for prophylaxis. No other adverse event details were reported. The outcome of the event was unknown.
This was an unusual presentation, it is not entirely clear is this was due to the vaccine (especially given the reaction history to naproxen in the past).  Patient presented with swelling below the left side of his lip to his chin, it then progressed to include the half of his lower lip.  He had no systemic symptoms (no respiratory, cardiovascular, or other skin symptoms).  No tongue swelling.  The area was painful, no vesicles/ulcerations, and non-pruritic.  He did not have a rash.  There was no local reaction at the site of the vaccine injections.   He was given IV methylpredisolone 40mg x1 with improvement (not complete resolution).   He was hypertensive on presentation which improved while observed and with reduction in swelling.  His lisinopril was stopped (although lower suspicion, but could not completely exclude); he last took lisinopril the morning of 10/26.  He was sent home on Zyrtec and a short course of prednisone 20mg.
Fever chills and flu like symptoms treated with Benadryl and Advil effectively pain at the injection site remains to date
Experienced Humira quit working; Experienced flare after first vaccine for COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4434891-00 (Agency).  A 61-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 1, single (Batch/Lot number: unknown) at the age of 61 years, on 08Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE; PREDNISONE. The following information was reported: CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "Experienced flare after first vaccine for COVID"; THERAPEUTIC PRODUCT EFFECT DECREASED (medically significant), outcome "unknown", described as "Experienced Humira quit working". The action taken for adalimumab was unknown.  Additional information :On an unknown date, the patient experienced Humira quit working. In 2021, the patient experienced flare after first vaccine for COVID. Pfizer Biontech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "experienced humira quit working" and "experienced flare after first vaccine for covid" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's assessment of the causal relationship of "experienced humira quit working" and "experienced flare after first vaccine for covid" with the suspect product(s) Humira (Adalimumab) was Probable at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Intense headache, sore throat, sinus congestion, runny nose, cough, intense fatigue (slept 17 hours one day), muscle and joint pain
Maculopapular, pruritic rash in multiple areas surrounding injection site starting on date of injection (posterior axilla, shoulder, and left arm distal to left deltoid from Moderna injection site). Red, raised, hive-like lesion to injection site at left deltoid starting the following morning 3/23/22. Left deltoid is slight swollen, hot, and tender to palpation. Tenderness and aching radiating into left breast, left chest wall mid-axillary line, and left scapula still present on 3/24/22. Rash resolved on 3/23/22, but hive on injection site still present today 3/24/22. OTC benadryl and ibuprofen used at home.
102 fever onset overnight. Continues to persist for 16 hours now. Chills. Headache. Upset stomach.
redness and swelling within 5 min of administration, swelling went down within 20 min and the patient was sent home without any treatment.  Patient returned to office on 2/28/20 with redness and swelling that started 2/26/20 was started on Keflex for possible infection.
Information has been received from a physician concerning a female pt who was vaccinated SC with a dose of varicella zoster virus vaccine live. Subsequently a few days after vaccination, the pt developed a linear blister at injection site. It was reported that the pt improved on an unspecified therapy and the pt recovered within a day. Medical attention was not sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/10/2006.  Information has been received from a physician concerning a female patient who was vaccinated SC with a dose of ZOSTAVAX (Merck).  Subsequently a few days after vaccination, the patient developed a linear blister at injection site.  It was reported that the patient improved on an unspecified therapy and the patient recovered within a day.  Medical attention was not sought.  There was no product quality complaint involved.  Additional information has been received from the physician's office which indicated that the patient had a light rash at the injection site for 24 hours.  There were no other problems and no work up.  No further information is expected.
Right Deltoid with evidence of punctuate vaccine mark with surrounding erythema approximately 6 by 6 with swelling and warmth to the area. No neuro radiculopathy.