chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt woke up 5/7/99 w/ c/o pain in lt arm;knot visible where vax given;rash down arm to mid forearm & through afternoon;pt seen by MD given ATB, DPH & APAP;
Sore arm; Delayed baseball size red area under injection site; Warmth at the site of the injection on left arm; Itching at the site of the injection on left arm; Rash at the site of the injection on left arm; Swelling at the site of the injection on left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (Delayed baseball size red area under injection site), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm) and VACCINATION SITE RASH (Rash at the site of the injection on left arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE REACTION (Delayed baseball size red area under injection site). an unknown date, the patient experienced VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm), VACCINATION SITE RASH (Rash at the site of the injection on left arm) and VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE REACTION (Delayed baseball size red area under injection site), VACCINATION SITE WARMTH (Warmth at the site of the injection on left arm), VACCINATION SITE PRURITUS (Itching at the site of the injection on left arm), VACCINATION SITE RASH (Rash at the site of the injection on left arm) and VACCINATION SITE SWELLING (Swelling at the site of the injection on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: New events; sore arm and baseball size red area below the injection site was added.
Arm pain "entire day" after vaccination.  At bedtime, noticed 2 fluid-filled "blisters" near injection site. Mild erythema around blisters.  No warmth noted.  No itching. Follow up on 10/24/2014-itching, blisters ruptured and crusted over.
Patient called stating she began having severe nausea and pounding headaches 1 week post-vaccination. She said she went to urgent care due to nausea. They tested her BP and it was fine. Said she is still having the headaches now, 1 week after they started.
2-3min p/vax pt had rxn similar to twin sibling-passed out-to ER IV fluids;
Itchy rash about 2-inch in diameter appeared around injection site on the following day and got better after 3-4 days, but reappeared one week after vaccination.
arm is red , sore, itchy, warm to touch. muscle is hard; arm is red , sore, itchy, warm to touch. muscle is hard; arm is red , sore, itchy, warm to touch. muscle is hard; arm is very red, sore, itchy, warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm is red , sore, itchy, warm to touch. muscle is hard), MYALGIA (arm is red , sore, itchy, warm to touch. muscle is hard), VACCINATION SITE PRURITUS (arm is red , sore, itchy, warm to touch. muscle is hard) and ERYTHEMA (arm is very red, sore, itchy, warm to touch) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm is red , sore, itchy, warm to touch. muscle is hard), MYALGIA (arm is red , sore, itchy, warm to touch. muscle is hard), VACCINATION SITE PRURITUS (arm is red , sore, itchy, warm to touch. muscle is hard) and ERYTHEMA (arm is very red, sore, itchy, warm to touch). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm is red , sore, itchy, warm to touch. muscle is hard), MYALGIA (arm is red , sore, itchy, warm to touch. muscle is hard), VACCINATION SITE PRURITUS (arm is red , sore, itchy, warm to touch. muscle is hard) and ERYTHEMA (arm is very red, sore, itchy, warm to touch) had not 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.   Concomitant medications were not reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received vaccine and felt neck swelling and chest tightness.; Patient received vaccine and felt neck swelling and chest tightness.; This is a spontaneous report from a contactable Health Care Professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6203), dose 1 intramuscularly on 26Feb2021 at 15:30 (at the age of 60-years-old) as a DOSE 1, SINGLE for covid-19 immunisation at Health Clinic facility. The patient medical history included rhinitis allergic, hypersensitivity, glucose tolerance impaired, headache, hyperlipidaemia, food allergy (fish and seeds/nuts) and gastroesophageal reflux disease all from an unknown date and unknown if ongoing. Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) 90 ug, TID (Three times a day) (albuterol 90 mcg/inh inhalation aerosol) 4 puff), fexofenadine hydrochloride (ALLEGRA), naproxen sodium (ALEVE) 220 mg, once a day orally, biotin (BIOTIN) as needed orally, colecalciferol (VITAMIN D 3) once a day, epinephrine (EPINEPHRINE) (EpiPen 2-Pak 0.3 mg injectable kit) 1 each (0.3 mg) Intramuscularly, garlic [allium sativum] (GARLIC [ALLIUM SATIVUM]) orally (garlic oral capsule), lisinopril (LISINOPRIL) (lisinopril 10 mg oral tablet; 1 tab 10 mg) orally, lysine (LYSINE) 1000 mg, once a day orally and probiotics (PROBIOTICS) once a day (3-10 billion CFUs) orally, all were taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccine in four weeks. It was unknown If patient had covid prior vaccination and If tested for covid post vaccination. The patient received vaccine and felt neck swelling and chest tightness on 26Feb2021 at 15:45. It was reported that, 1538 Patient received vaccine and felt neck swelling and chest tightness. Patient received treatment for the event which was reported as, patient refused Benadryl and stated it knocks her out. Patient took 2 puffs of her prescribed Albut. Outcome of the event was resolved in 2021.  No follow-up attempts are possible. No further information is expected.
Patient had syncope and sweating, BP 141/84, HR87, RR18. Given OJ and monitored, patient was stable and discharged in stable condition
This is a spontaneous report from a contactable consumer.  A female patient of unspecified age and ethnicity started to receive PREVNAR 13, via an unspecified route of administration, on 19Nov2016, as single dose for immunization. The patient's medical history and concomitant medications were not reported. On 22Nov2016, the patient experienced soreness around injection site following injection and rash around injection site. The outcome of soreness around injection site following injection and rash around injection site was unknown.
Patients received expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patients received expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter. Two vials where used 14 patients received the vaccine on 19OCT2021 and 8 patients on received the vaccine on 22OCT2021.expiration date the vaccine was on 12OCT2021. This case was linked to MOD-2021-363630 (Patient Link).
Client  received the  Janssen dose lot # 1808980 and expiration date  6/20/21 at 11:01AM.  At 11:16AM client had already waited their 15 minutes and reported to EMT  that she was having shortness of breath and anxiety. Vitals were taken : Oxygen: 97%, Blood Pressure: 130/80, pulse=75.  Client reports to EMT s that she has a history of bradycardia and anxiety. Client reports medications are amlodipine 5 mg, Irbesartan 50 mg, Aspirin 81 mg PO, inhaler for asthma.  Client also reports that on January 8th of 2021 she tested positive for COVID-19.   PHN was notified at 11:28AM of client's symptoms. PHN arrived to find client sitting upright and alert and oriented x 4.  Since client had shortness of breath reported PHN offered 9-1-1 but client declined, stating she was already feeling better. PHN advised client to stay an extra 30 minutes since she had a reaction. Client reports she thinks it is because she forgot to take her inhaler dose this morning. Vitals were taken: respiration rate=20, Blood pressure 130/70 and oxygen 96% and pulse 55. Client then reports she also has a history of high blood pressure. Client reports that earlier she felt a little lightheaded but did not report to EMTs.  At 11:31AM vitals were blood pressure: 146/80, oxygen:97%, pulse: 65 client reports she no longer had shortness of breath, no dizziness no headache, no blurred vision and no chest pain.  Gave client water bottle. At 11:41AM vitals were pulse:70, blood pressure: 130/80, oxygen: 97%- client reports no shortness of breath and "feels great."  PHN advised client of emergency precautions and to follow up with provider.  At 11:46AM: blood pressure: 132/90, oxygen: 98%, pulse: 68.  At 11:50AM client left facility with steady gait.
13 month old boy received 1st dose of MMR vaccine on 11/19/2021. He developed rash at injection site immediately after vaccination, followed by fever, runny nose, cough on 11/20/2021. Patient was diagnosed with croup on 11/22/2021 and treated with dexamethasone. On 11/23/2021, patient developed bilateral suppurative otitis media which was treated with antibiotics.
feeling dizzy; This is a spontaneous report from a contactable consumer (patient). A 44-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number was not reported, Expiry date was not reported). via an unspecified route of administration, administered in Arm Left on 10Feb2021 15:30 (at the age of 44 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported, no known allergy was reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks. The patient's concomitant medication included Amfetamine Aspartate, Amfetamine Sulfate, Dexamfetamine Saccharate, Dexamfetamine Sulfate (Adderall) taken for an unspecified indication, start and stop date were not reported. On 12Feb2021 07:30, the patient started feeling dizzy. Patient received no treatment for the event. The outcome for the event was not recovered.   Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
FEVER : IBUPROFIN & TYLENOL  SHORTNESS OF BREATH LOW SATURATION LEVELS (LOW AS 94%) MIGRAINE: TYLENOL BACK PAIN: TYLENOL PAIN AND MUSCLE TWITCHING AT INJECTION SITE NIGHT SWEATS UNCONTROLLABLE SHAKING TIGHT/SCRATCHY  THROAT CHEST PAIN/TIGHTNESS DRY COUGH BRAIN FOG
This case was reported by a consumer via call center representative and described the occurrence of loss of energy in a adult patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of asthenia (For tolerance to 1st dose please refer case US2018GSK219956). On 29th November 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced loss of energy, dizziness, increased blood pressure and feeling anxious. Rechallenge with SHINGRIX was positive. On 3rd December 2018, the outcome of the loss of energy, dizziness, increased blood pressure and feeling anxious were recovered/resolved. It was unknown if the reporter considered the loss of energy, dizziness, increased blood pressure and feeling anxious to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had all the side effects experienced after the first shot but only for 1-1 and half days, then  continued to experience some side effects on and off until 3rd December 2018. On the day of reporting, this was the first day patient have energy, no dizziness. The patient also had elevated blood pressure for that interval and had a feeling of anxiety. At the day of reporting the patient was without those feelings and blood pressure was back in line. The patient went to physician. Lab Comments: Lab test was done on an unknown date.
It began in my legs - on both sides at the same time - my legs became sort of jelly like - my knees would suddenly buckle underneath me (I first noticed it when I was on the treadmill - my legs buckled under me and felt progressively weak....this continued and then began to move up my body...fortunately, the weakness as it moved up through my body over the course of the next few days or weeks (I no longer recall) was mild. However, it was pronounced enough to make my doctor realize what was happening and guess that perhaps the H1N1 vaccine had been the cause.  However, when he questioned the authorities, they denied any connection and said there had been no other cases reported. However, this year, when I went to get a flu vaccine, I was told by the clinic that because I had had Guillain Barre, I was not permitted to get a flu vaccine this year.
Systemic: Stroke-Severe, Additional Details: Spouse of patient states that wife fell on 6/2/21 and went to the emergency room. States that MD said patient no histoy of blood disorder and believes patient got a stroke due to COVID vaccine. Currently taking blood thinners for incident. Now has trouble speeking due to blood clot/stroke.
I experienced dizziness, fainted, and hit my head which caused a visit to Urgent Care who sent me to the ER. The doctor did an X-ray on my head and was referred to a Neurologist; however, the Neurologist failed to submit the paperwork to perform  an MRI to my insurance company. I decided not to reschedule because my appointment would have taken place 3 months later.
Nov. 3, 2021 Severe neck and shoulders pain for followed by sharp, burning R flank pain intermittently but constant. VZV test 29, Nov DIagnosis November 3, 2021  Shingles, NO rash or lesions. Prescribed, Famciclovir
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient, self-reported). This 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On 17Apr2021, Saturday, the patient tested positive for COVID-19. On unknown date in Apr2021, a week ago, the patient tested negative. On 19Apr2021, The patient scheduled to receive the second dose of the vaccine today.The patient wants to know if she should reschedule or proceed with her second dose today. The patient underwent lab tests and procedures which included tested for COVID-19 was positive on 17Apr2021, Saturday. Outcome of the events were unknown.  Information about lot and batch number was requested.
Patient complains of soreness in shoulder and upper arm, says cannot raise arm above shoulder level, states started with initial soreness in arm at vaccination site (left arm).
24 hours after shot,I  began to run a low fever, chills. Lasted only 12 hours, acetaminophen used to alleviate discomfort.  2 weeks after shot, redness in left arm remains, both at injection site and below. Redness has lessened daily, but still there after 2 weeks.  A large(silver dollar size) knot is still present in arm, over 2 weeks later. Went to pharmacy, he said  it seems fine but to report to you for record-keeping. No  pain or lessening of arm function has been noted now, or immediately after injection.
No AE; 6 month old patient inadvertently received a dose of MMR II and VARIVAX.; This spontaneous report was received from registered nurse and refers to a 6-month-old patient of an unknown gender. The patient's medical history, and concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 05-APR-2023, the patient was inadvertently vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA) subcutaneous injection, 0.5 milliliter, lot #W007182, expiration date: 01-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W006413, expiration date: 23-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided) (product administered to patient of inappropriate age). There was no adverse event reported.
Heavy soreness to right arm-pain started Friday evening. Rectangle shaped rash around injection. Swelling of injection site. All started the evening of injection. Symptoms subsided today 12/11/06.
Respiratory therapist received flu vaccine as part of our hospital's flu program where we give flu shots to staff on our unit. I am the administer for our unit and my assistant administered with a non-refrigerated dose. I had accidentally left a box of three doses out for a few days in my box of supplies (because it looks very similar to our band aid box), and was unsure what to do with it. I didn't hear back until several days later from the coordinator, so I left them with the supplies. I was giving them out that day, so I was aware that they were not to be used until I heard back from clinic. However, my assistant, jumped in and gave the doses to the respiratory therapist. I should have labeled the box as "do not use" and so I take responsibility for the error. I reported the incident immediately and we offered to revaccinate. This individual chose not to revaccinate since she is breastfeeding her child and was worried about receiving another dose. We did provide full education from the pharmacist recommending re-vaccination since the former dose was out of the refrigerator for > 72 hours and was considered ineffective. However, she still chose not to be revaccinated. I spoke with her following the injection and the only symptom she described was a sore arm following her injection.
12 day p/vax pt exp blood in stools x5 + episode of vomiting, skin cold & clammy. some sweats, stool foul smelling, acting as if in pain; barium enema reduction of intussusception
Received DTAP, HIB and PREVNAR on 6/29/09.  Fever occurred several hours later - sleepy that day & fussy that evening.  3 loose stools & 1 emesis 6/30/09, 7/2/09 diarrhea, vomiting & increased temp.
mom stated pt got a rash p/vax 27MAR98;rash still present on 30MAR98;took pt to MD 30MAR98;MD said it was poss rxn to vax & not to given HIB in future;
Within 45 mins of receiving H1N1 vac patient began to itch and broke out with hives.
migraine, neck pain, nausea, tiredness x 4 days. Symptoms returned at day 10 and lasted until day 15 after initial vaccine
reaction at the injection site that consisst of swelling and redness bigger than the size of a quarter; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves five patients who experienced reaction at the injection site that consist of swelling and redness bigger than the size of a quarter (inflammation), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patients developed a non-serious reaction at the injection site that consist of swelling and redness bigger than the size of a quarter (inflammation) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was inflammation.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for inflammation.  Information on the batch number was requested.
On 4/6/2021 woke up with severe left muscle cramp in left leg. Next 3 to 5 days tried massage, ice, compression and Motrin - no relief. Did no treatment for the next couple of days. Went to primary care doctor and then got an ultra-sound on 4/14/2021 at clinic  - by Doctor. Results showed had three blood clots in left leg. Started on Eliquis that day.
Severe stiffness and pain in neck on right side (the vaccine was administered in the right arm).
21y/o female presenting after developing rash after smallpox vaccine.  This was pt's 2nd smallpox vaccine (1st in 2000 when pt was abroad; no reaction after that one).  Pt provided pictures of her rash progression.  2 days after her smallpox vaccine, pt has small erythematous macules/papules over her face and chest.  Itchy and pt treated with Benadryl.  Skin completely recovered for 1 week, then pt developed diffuse and progressive erythematous macules to patches over face, chest, back, abdomen, legs.  The lesions were well demarcated, raised, circular, and clumped together.  +Itchy.  Lesions did not wax/wane but worsened to maximal in 2 days, and then took 2 wks to completely resolve.  Pt also had upper lip swelling.  No oral lesions.  Pt was seen in ER and treated with Benadryl which only made her sleepy.  Medrol dosepak helped the most.  Pt also took Zantac, Claritin, and Zyrtec.  Denied any vesicles, crusts, flaking/peeling of lesions.  Erythematous patches resolved without any scarring.  Today pt has faint pink patches over arms of where lesions were.  The smallpox site is crusted over.  Pt's pictures did show her smallpox vaccine site was also large erythematous beyond the bandaid area during the worst part of her reaction.