chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 29-MAY-2012, the patient was administered with a dose of VARIVAX (Merck) (Lot # 0345AA expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of 121 reports received from the same source. Additional information has been requested.
Developed macular rash, malaise, pruritis and regional (axillary) lymphadenopathy 14 days following smallpox vaccination (e.g. generalized vaccinia).  Otherwise normal vaccination reaction.
Reports that shoulder started to hurt 1 to 2 days after receiving HINI vaccine (vaccine received 12/29/2009).  Client states that shoulder pain progressively got worse over the next few weeks and now reports pain as 8 out of 10 (0 to 10 pain scale with 10 being absolutely unbearable).  Client reports intermittent muscle spasms to chest wall and to distal portion of arm.  No redness, no swelling, and no drainage proximal to injection site.  Observed significant guarding to left shoulder and pained expression on face when asked to extend arm 90 degrees and forward and back.  Hand is warm and dry to touch and there is no overt discoloration.  Client denies injury/trauma to arm/shoulder and denies significant medical history (including cardiac history).  Client denies trying any palliative measures.  Reports NKA.  Referred to local community clinic for follow up; instructed to consider ER if pain worse or additional symptoms occur.
The second dose was prepped by adding normal saline into the vial in front of her before being administered.; The second dose was prepped by adding normal saline into the vial in front of her before being administered; Caller reported hair loss post vaccination/Second dose: she has a hair brush and it's full of her hair; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. A 63-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on 21Apr2021 (age at vaccination:63 Years) as dose 2, single for covid-19 immunisation. Patient did not received other vaccines within 4weeks prior to vaccination. Medical history included left mastectomy from an unknown date and unknown if ongoing, chemotherapy from 2001 to an unknown date she had chemotherapy about 20 years ago. The patient concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on 21Apr2021 as dose 1, single for covid-19 immunisation. The caller reported hair loss post vaccination/second dose: she has a hairbrush and it was full of her hair on 2021. The second dose was prepped by adding normal saline into the vial in front of her before being administered on 21Apr2021. She reported she cannot have anything done to her left arm as she had a left mastectomy. She started to notice her hair loss about a week after receiving the first Covid 19 vaccine. She knew she was losing her hair because the hair loss was the same as when she had chemotherapy about 20 years ago. When probing for information on her medical history and concomitant medications she reports she had been taking all her medications normally. She also tried to rule out the hair loss being related to any of her medications, but nothing has changed. She added that with the second Covid 19 vaccine she reported the nurse drew up sterile saline, added the sterile saline to the Covid 19 vaccine vial, then withdrew from that Covid 19 vaccine vial a dose and administered the Covid 19 vaccine. This did not make any sense to her. The nurse told her it was, so the vaccine lasted longer. The outcome of the event alopecia was not recovered and the outcome of the events product preparation error and poor quality product administered was unknown.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported. No Treatment medication reported.   This case was linked to MOD-2021-409881 (Patient Link).
Awakened in early morning w/significant pain in arm; area of shoulder involved-reddened, sl swollen & very tender to touch; site of inject appears normal-no redness or swelling;
Rash to neck, face, trunk area, arms, and right thigh. No fever, no SOB, no respiratory problems reported. Pt was given BENADRYL 25 mg.
Administration error. Patient was 17 when vaccine was administered (authorized for 18 and older). No known adverse events.
Big red swollen area around injection  like a allergic reaction to spider bit.  Throbs hot and sore and swollen and is getting bigger ea day
Narrative:  Pt reports mild dizziness at 15:55 after receiving Pfizer vaccine. This RN alerted Vaccine Lead RN who came to vaccine station to assess patient along with this RN. Vitals at 15:55: 118/68 HR 79 R 17 O2 sats 98% RA. Pain 0/10. Pt AAOX4. Pt alert and appears in no acute distress. Pt received juice and almonds and reports symptoms resolved at 16:10. Pt monitored until 16:35. Pt left clinic without requiring or administrating medications. States he is at his baseline and denies any complaints at time of discharge from vaccine clinic. Additional vitals taken: 16:05 BP: 130/78 P: 78 R: 17 O2 sats: 98% RA 16:17 BP: 126/59 P:77 R:17 O2 sats: 97% RA pain:0/10 16:28 BP:128/59 P:71 R:17 O2 sats: 98% RA
Hospitalized 9/13/21; COVID 19 + on 9/13/21; fully vaccinated.
pt recvd 1st dose of vax w/no noted problem; Pt recvd 2nd dose of vax 18AUG92 & w/in an hr following vax, pt exp sore arm w/pain @ inject site; sx resolved w/in 24 hrs; No further details were provided;
Hives and Rash on body more on front stomach and  both thigh areas  saw my pCP dr Agarwal , continue Benadryl 25 mg three times a day  then start  prednisone10mg as prescribed from tomorrow if rash does not get better  second dose was on   Feb 2nd  and reaction on 15 th FEb
Erythema [illegible word] face and body with hives; spontaneously resolved in less than 1 hour. [illegible word] of asthma. Prescribing antihistamines for allergies.
No symptoms for 24 hours. The following evening, having dinner and started to feel lightheaded. Within seconds I was unresponsive for what appears to have been just over 1 minute. My wife called 911 and I was starting to come to while she was wrapping up the call with the dispatcher. I remained seated upright, did not fall over, but was completely unresponsive.  When the EMT's checked vitals (within 5 minutes of me coming back to awareness), all was normal. Simply a full body cold sweat. It's now 10pm and I feel no other symptoms. Completely "normal".
received Kinrix when was 2 YO; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 75F53, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th April 2018, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th April 2018, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient was 5 years old at the time of reporting. The patient younger than indicated age, received a dose of Kinrix at 2 years, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
No adverse event; Dose was administered to patient with lot 215K22A before use date 20-Jan and given on 23-Jan; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered to patient with lot 215K22A before use date 20-Jan and given on 23-Jan) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered to patient with lot 215K22A before use date 20-Jan and given on 23-Jan). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was administered to patient with lot 215K22A before use date 20-Jan and given on 23-Jan) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose was administered to patient with lot 215K22A before use date 20-Jan and given on 23-Jan).    No concomitant medication were reported.  Stated that a dose was administered to 3 patients after the 30 days use by date wherein Moderna vaccine lot 044C22A beyond use by date (BUD) was 22-Jan-2023 and was given on 23-Jan-2023 and for lot 215K22A BUD was 20-Jan-2023 and was given on 23-Jan-2023.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706705 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jan-2023: Non significant live follow up On 31-Jan-2023: Follow up includes no new information. On 31-Jan-2023: Follow-up information received includes primary reporter details were updated. On 15-Feb-2023: Follow-up received included updated patient demographics, suspect vaccine batch number and event verbatim.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706705:Master Case
received vaccine while seated, fainted within approximately 30 seconds. Provider lowered her head, when no responsiveness after approximately 30-60 seconds, called 911. regained consciousness within approximately 60-90 seconds. She was alert and responsive when EMS arrived. Was taken by ambulance to hospital due to low blood pressure and persistent dizziness.
DYING FROM PAIN; FEVER 99-100.8 F AS IF GOT THE SHOT AGAIN; CHILLS AGAIN; SEVERE PAIN IN THE LEFT LEG FROM HIP TO KNEE, THE WHOLE LEFT SIDE; FUNCTIONABLE DURING THE DAY  BUT NOT AT NIGHT; CAN NOT SLEEP AT NIGHT; BOTH LEGS HURT AT GROIN; CRIES FROM THE SEVER PAIN; INCREASE IN THE BLOOD PRESSURE; DEHYDRATION WHICH MADE HER VERY THIRSTY; FELT BURNING IN THE RIGHT ARM WHILE GETTING THE SHOT; SWOLLEN FACE; SEVER CHILLS; FELT EXHAUSTED; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included hip implant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood pressure measurement (NR: not provided) increased, COVID-19 virus test (NR: not provided) negative, Hip X-ray (NR: not provided) normal, and Investigation (NR: not provided) Negative. On 31-MAR-2021, the subject experienced increase in the blood pressure. On 31-MAR-2021, the subject experienced dehydration which made her very thirsty. On 31-MAR-2021, the subject experienced felt burning in the right arm while getting the shot. On 31-MAR-2021, the subject experienced swollen face. On 31-MAR-2021, the subject experienced sever chills. On 31-MAR-2021, the subject experienced felt exhausted. On 14-APR-2021, the subject experienced functionable during the day but not at night. On 14-APR-2021, the subject experienced can not sleep at night. On 14-APR-2021, the subject experienced both legs hurt at groin. On 14-APR-2021, the subject experienced cries from the sever pain. On 14-APR-2021, the subject experienced severe pain in the left leg from hip to knee, the whole left side. On 16-MAY-2021, the subject experienced fever 99-100.8 f as if got the shot again. On 16-MAY-2021, the subject experienced chills again. On an unspecified date, the subject experienced dying from pain. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increase in the blood pressure, and dehydration which made her very thirsty on 05-APR-2021, felt burning in the right arm while getting the shot on 2021, swollen face, sever chills, and felt exhausted on 14-APR-2021, and fever 99-100.8 f as if got the shot again, and chills again on 21-MAY-2021, had not recovered from severe pain in the left leg from hip to knee, the whole left side, functionable during the day but not at night, can not sleep at night, and cries from the sever pain, and the outcome of both legs hurt at groin and dying from pain was not reported. This report was non-serious.
9.5 cm x 5.0 cm erythematous lesion surrounding site of injection - upper (R) thigh.
Mom observed that pt was in bed & legs were extended p/a few seconds the pt had jerking movements mom took temp & it was 104;
Since my daughter received the second dose of the HPV vaccination, she has had chronic headaches, extreme fatigue,  lightheadedness upon standing and occasional fainting.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707457, expiration date was reported as 22-FEB-2022 but upon internal validation established as 23-FEB-2022;  lot # 1707460, expiration date was reported as 13-MAR-2022 but upon internal validation established as 14-MAR-2022) underwent a temperature excursion.  On 09-JUN-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported) orally for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 47.2 Fahrenheit (F) (above 46 F) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004356:
Mother says that baby was seen for 1st shots and told to sign papers to get shots including Rotavirus. The next day, after feeding, the baby began to vomit and was having diarrhea approx. 15 minutes afterwards. Repeated episodes after each feeding. Went back to clinic and was given a container to collect stools. Was later told that it was not diarrhea and formula was changed. He continued to have episodes. Called HC and seen there on 11/9/01.
Shingles - I caught it pretty early. The nerve pain began Saturday afternoon and continued through Sunday. Monday morning after the rash started, I scheduled an appointment with the Health Center and they were able to see me that day. I was quickly diagnosed with shingles. It was located on a band on my left chest, neck, shoulder, and back of my ear. The nerve pain lasted almost 3 weeks. The rash has mostly faded by now (4/27). I was given 7 days of Valacyclovir to treat.
Patient states his arm was sore and tender at shoulder above injection site for up to 7 months post injection to the point where he couldn't sleep on his left side.
forgot to take 2nd shot/ more than 6 months; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient received 1st Shingrix shot and forgot to went back for the 2nd one. The patient asked that he/she did need to start over or could take the 2nd even though it had been more than 6 months. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd shot of Shignrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
pt recv vax 6JAN96 & 12JAN96 pt devel a fever, cough, & runny nose;pt recovered;
No adverse event. Patient received wrong stock of vaccine. Patient should have received Flulaval but got Fluarix. Patient stated that he felt normal. No symptoms.
When prepping vaccine tray for this patient (with no vaccine history) I grabbed the Tdap instead og the Dtap
11/17/04 Fine; waited for about 3 hours received shot. That night, tired and stayed home. 11/18/04 Didn't feel well, throat swollen, couldn't eat or drink much and was listless. 11/22/04 Went to PCP and saw the PA. Checked out ok and sent home. 11/22/04 Went to ER with same complaints as 11/18/04 and was admitted to hospital with dehydration and swollen throat. Stayed in hospital for 8 days. Was released on 12/1/04 to go home. According to wife, he is still very tired and listless. Doesn't eat much or drink much either. Is currently under the care of a nephrologist and also his PCP. Follow up 03/08/05: Patient's recovery status is unknown.
pt recv vax 01MAR94 & the next day pt exp malaise & a sore throat; MD felt that pt may have had a mild viral URI; by 08MAR94 pt had fully recovered;
Patient developed rash and hives after receiving the Fluvirin vaccine. Recommended that patient start taking oral diphenhydramine to treat allergic reaction.
Patient had heat/fever at site of injection. Patient also had redness and swelling arranged in a circle and radiating approximately 3-4 inches from the center. After 3 days, the patient had a large blister (about 2 inches long and 1 inch wide) filled with fluid. The skin surface almost looked burned and very swollen. The patient had to be seen by physician, given a round of antibiotics, steroid dose pack, and also a cream to help with skin irritation/burn. The doctor dressed the arm with a compression wrap and had patient followup 2 days later for redressing.
lot of blood came running down from right arm; black a blue bruise on the site; This is a spontaneous report from a contactable Consumer, the patient. A 72-year-old non-pregnant female patient received first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in right arm on 09Mar2021 at 15:00, as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included ramipril (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN) all for an unknown indication from unknown dates. The patient was not allergic to medications, food, or other products. Prior to 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 vaccination. On 09Mar2021, the patient experienced vaccination site bleeding and bruise. The clinical outcome of vaccination site bleeding and bruise was not recovered. The patient didn't receive any treatment for the events.   No follow-up attempts are needed. No further information is expected.
Collapsible left arm pain/ he would raise his arm it would just drop because it hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Collapsible left arm pain/ he would raise his arm it would just drop because it hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Collapsible left arm pain/ he would raise his arm it would just drop because it hurt). At the time of the report, PAIN IN EXTREMITY (Collapsible left arm pain/ he would raise his arm it would just drop because it hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. It was reported that Without any HCP's suggestion, the patient had used over-the-counter Tylenol and ibuprofen for the symptoms.   This case was linked to MOD-2021-064148 (Patient Link).
6 days after I got the vaccine, I noticed a large rash across my torso.  I am unsure if the rash was developing prior to when I noticed, but the rash is on my stomach and part of my lower back.  I finally visited my primary doctor today and was told the rash is a drug reaction - it is not itchy nor painful.  **I am supposed to be on baby aspirin indefinitely due to my heart condition.  I have not taken baby aspirin in a few years.  But after there were reports of women getting blood clots after getting the JNJ vaccine, I started taking baby aspirin 6 days after I got the vaccine.  The rash may have happened before or after I took my first dose of baby aspirin.  I stopped taking baby aspirin the following day.   Today, my doctor advised me to stop taking all Vits and Supplements.  I will be taking Zyrtec and Tagamet for next 10 days, hoping the rash will go away.