chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; Medical assistant reported ROTATEQ  was administered after temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 14-AUG-2023 and 28-AUG-2023, temperature excursions were reported at 8.9C for 12 hours and 20 minutes and 9.4C for 8 hours and 20 minutes, respectively. No previous temperature excursions were reported. On 25-SEP-2023, the patient was vaccinated with an improperly storage (Product storage error) rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, valid lot #1968393, expiration date: 24-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided). No additional adverse event was reported.
Pt experienced fever and weakness after 3rd dose in post exposure series. Resolved in less than 24 hours.
Muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO) for Coagulation disorder, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain) and CHILLS (Chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle pain) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-382995 (Patient Link).
Redness and swelling at site of injection. Called care provider on 8/9/02 to report. Pt was active, playing, and afebrile. Home care treatment with instruction to take pt to cc if needed.
Fever, sore arm at injection site, headaches, rash at injection site. Took Tylenol several times over course of 24 hours.  Symptoms almost completely resolved within 48 hours.
COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced COVID-19 (COVID-19). On 07-Apr-2021, COVID-19 (COVID-19) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test positive: positive (Positive) Positive.     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 product is not provided. No treatment information is provided.  Reporter stated the patients quarantine period would end on 07APR2021 and second dose was scheduled 08APR2021.
Dizziness Lightheadedness Nausea Monitored for 30 minutes total; no intervention required and released to home.
PFIZER SEVERE SKIN ALLERGIC REACTION WITH SEVERE ITCHING AND WELTS/ BLOTCHES ON SKIN ALL OVER BODY.  RED LARGE RAISED BUMPS. PINS AND NEEDLES RED AND HOT
Pfizer 2/22 and 3/15 and 10/11. Positive on 11/10
This non-serious event was reported by a health care professional in a country on 13 January 2009. This patient is one of a cluster of 20 patients; the other 19 patients are captured in case numbers 2008-03509, 2009-00153 to 2009-00163, and 2009-00165 to 2009-00171. A male patient, had received an injection of FLUZONE SV 2008-2009 (lot number U2762AA); however, the date, route and site of administration were not provided. On 29 October 2008 the reporter recorded that approximately three hours post-vaccination, the patient's throat felt like it was swelling; his eyes were red, he had a fever and chills and he was experiencing weakness. The patient missed on day of school. It was not reported whether the patient required medical evaluation, or if he received any treatment. Outcome was not reported. Follow-up information was received from the health care professional on 13 February 2009. The patient was 45-years-old at the time of the event. On 29 October 2008, he received an intramuscular deltoid injection of FLUZONE. He did not require any treatment, and all events recovered with 24 hours. Documents held by sender: None.
After shots, walked to check out area.  Became pale and weak.  Sat in chair.  With help, walked back to room.  Laid down, AP 60+, BP 102/72, went home, nap, fine next day.
Pt (patient) is complaining of right arm soreness. Pt is feeling better and there is no restrictions of movement.
HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious.
This is a spontaneous report from a contactable physician and non-contactable consumer via a Pfizer sales representative who reported similar events for two different patients. This is the second of two reports. A 16-year-old male patient received TRUMENBA (NDC number 0005-0100-10) first dose on 21Apr2016 at 08:55 (lot M95612, expiry date Jul2017), second dose on 21Jun2016 at 09:30 (lot M95612, expiry date Jul2017), third dose on 19Oct2016 at 09:50 (lot N11903, expiry date Jul2017), each one intramuscular, at 0.5 ml single, in the left thigh, for immunization. Prior vaccinations within 4 weeks before: none. The patient medical history was not reported. Illness at time of vaccination: none. Concomitant medication included a booster dose (2nd dose) of MENACTRA (Manufacturer: Merck, lot: U5259AA, expiry date: May2017, NDC:49281-589-05) intramuscular, in right thigh, on 21Apr2016, at 0.5 ml single, for immunisation. The previous dose of MENACTRA was given when the patient was 11 years old. The patient experienced fatigue and had a dramatic decrease in speed and endurance, both since an unspecified date in 2016, right after the first dose of vaccine. The coach noticed the boy on the high school running team had a dramatic decrease in speed and endurance and also had fatigue. The boys run 60 miles a week. He was an athlete and could not perform. His pulse was monitored every day. The events did not require an emergency room or physician visit. The events resolved on an unspecified date and the patient resumed being able to run again. The physician did not know about the events until after all 3 doses of vaccine had been given. The physician thought the event could be related to TRUMENBA. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017056823 same reporter/events, similar suspect drugs, different patient.
feel Funky; Headache; Low energy; sinus kicked in with runny nose; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received second dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. On an unspecified date, the patient felt funky, had sinus issues on friday and on saturday had headache and low energy and sinus kicked in with runny nose, was fine by sunday. The patient informed that he had no problems with first dose and also asked whether it was true that the vaccine was good for 6 months, he was told this by a registered nurse (RN) at the vaccination site. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt stated before getting vaccinated that first vaccine she got hot, diaphoretic and felt like she was going to  passout. Pt placed in a wheelchair before getting vaccinated. 10:27 pts mom reported that she was "hot & sweating". PT reported that she was a little dizzy too. 10:30 BP 94/62, HR 96, RR 20. Patient wanted to  lay down. RN and Mom assisted to the cot but patient momentarily fainted. She quickly responded to her name. Pt place in Trendelenburg. PT reported that she was feeling better, pt sat up at side of cot 10:37. Rpt still a little hot but no more dizziness. 10:40 BP 94/58, rr 16, HR 82. 1042, stood up to transfer to chair, rpts no symptoms anymore. Gave some water. Patient left 1039 with moms verbalizing understanding to call physician or 911 if any onset of symptoms.
day after vaccine developed large raised red skin lesion at the injection site spontaneously went away after 2-3 days recurred again with similar appearance about 4-5 days after vaccine administration skin lesion is itchy and red, but no other symptoms
Vaccine administered around 3:50pm - around 6:00pm, she complained of arm pain, which is standard, so I gave her Tylenol for the pain.  at 6:05ish, she became verbally unresponsive, staring off into space, not focusing on me.  I picked her up and gave her a sip of water, which she bubbled back out of her mouth.  I was then very concerned at this point - she was very pale, but breathing normally - no fever spiked at all this entire time or leading up to the event.  I then brought her upstairs and laid her down on her changing table - her eyes were almost closed and very glassy.  I then went to pick her back up and her body went limp (head flopping/hanging backwards).  I then called EMS -they were no help; they did not check her vitals or anything upon arrival.  When they did arrive around 6:30, she started to smile and respond a little bit via facial expressions (acting shy, etc.).  She did eat dinner around 7pm - ate normally.  She was starting to come out of it, responding more verbally, but still not 100% herself.  She then had the shivers - but still no fever.  I snuggled with her in a blanket.  Around 7:40pm she bounced back to her normal self.  I monitored her overnight.  No fever and responded when I poked and prodded her to make sure she was ok.  She woke up today totally  normal.  I brought her in to the doctor to check her vitals and all are normal.
I had a rash and soreness of the arm lasted for a week.  I felt very fatigued which lasted about 4 days.  I also had hot flashes as my temperature did not regulate.
Pt reports numbness in right hand and pain in finger tips, low back pain, fever, chills
They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant medications details were reported.  Patient received vaccine at Pharmacy.  Beyond use date of the vaccine was 01-Jul-2021.  No treatment medications details were reported.  NDC number was reported as 80777-273-10.    This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received wherein patient and vaccination details added. Case narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Pfizer-BioNTech COVID-19 Vaccine EUA: one month after receiving immunization patient hospitalized for septic shock, spontaneous bacterial peritonitis, and pelvic mass found to be malignant (carcinosarcoma). Underwent paracentesis, laparotomy, and received antibiotics. Discharged medically stable.
Mother returned with child approximately 1/2 hr after he received immunizations. Generalized rash on all extremities bilaterally. No rash noted on trunk. Mucous membranes pink. Rash over cheeks. Eyes swollen. Child itching. Ambulance called. Child transported to ER.
Tremors. Lasted approximately 30 seconds. Continue to have tremors about 1 time per week that is noticed.
Patient went to primary care doctor and was diagnosed with a shoulder injury due to vaccine given too high. She was given a Medrol dose pack for inflammation and pain.
tinnitus; vertigo; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In or around 24-MAY-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the vaccine, the pt suffered severe ringing and buzzing in the ears, dizziness, severe headaches and neurological issues, and was diagnosed with tinnitus and vertigo. As a direct and proximate result of the company's defective zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of vertigo and tinnitus was reported as not resolved.  The causal relationship of the events was reported as related to zoster vaccine live (ZOSTAVAX). The reporter considered vertigo and tinnitus to be disabling events.
Received a phone call from patient to report that she has been having a problem with her arm since she received her flu shot on Friday 11/07/2003.  Got it about noon then went and worked a 12 hour shift.  By the time she got home it was very tender, hot and swollen.  Tried to just wait for it to get better but on Monday called her care provider and went in to get it checked on Tuesday 11/11.  Was put on Keflex three times a day and Motrin 800mg three times a day.  Went back to provider again this week and Keflex was increased to 4 times per day and Vicoden was added.  Has an EMG scheduled for 11/26.  Reports it remains swollen and if she does not take pain pills she can't lift her arm to put on deodorant or other such moves.  Will give update after she has the EMG and knows more about what's going on.
This case was reported by a pharmacist and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shingles following day of vaccination. The reporter stated that one of the colleague had a report of a customer receiving a SHINGRIX vaccine and got Shingles the following day. She was following up with the patient on the day of reporting and would involve risk management as necessary. She would ensure it was reported to the authority. Likely that was unrelated, but customer perception was that the vaccine gave her Shingles. Another reporter reported that based on the conversation with the supervisor on the day of reporting, the patient got a clean bill of health just weeks prior with the recommendation from her physician to get the vaccine. It appears to the reporter that the onset of Shingles was well on the way when the patient received the vaccine from their pharmacy.
Breakthrough case admission after two Janssen vaccines Janssen 5/14/21 Lot# 1802070;  Janssen 12/16/21 Lot# 1822809
Initial unsolicited report received from an other-health care professional (vaccine provider) on 29 September 2016. This case involves 8 patients (age and gender were not reported) who were vaccinated with Fluzone QIV intramuscularly (batch number: UT5629LA, expiry date: 20 June 2017; dose, dose in series and site of administration not reported) on 20 September 2016. The patients' medical history and concomitant medications were not reported. On 20 September 2016, same day after vaccination, the patients' reportedly had symptoms of malaise, fever, chills, bodyaches and headaches. Laboratory data and corrective treatment were not reported. The outcome of the events was unknown. List of documents held by sender: none.
This is a 58-year-old male patient No significant past medical history Received only 1 dose of moderna vaccine in July Did not complete covid vaccination Came into the ER with a complaint of shortness of breath and fever Patient to come covid test that was positive
Reaction is local to injection site, with no systemic reaction. A circular rash at the site of injection measuring 3.6 mm, Site is swollen & erythematous. Injection was given on 11/8/17. On 11/9/17 the patient noticed the rash. On 11/10/17 at time of my observation the rash is still present with the same symptoms listed above. The patient also complains to significant pain at site. Patient will apply ICE intermittently for the next several days & the rash will be monitored. FLUARIX was placed into patients chart as an allergy/adverse reaction & she was advised not to receive FLUARIX brand flu shots. Patient received a FLUZONE QUADRIVALENT during last years immunization, which she did not have any adverse reaction to.
pt recvd vax 28SEP95 & got rash on trunk 5OCT95; on 7OCT95 started running fever; had sz on 8OCT95 highest temp 102 R
Red, raised rash on mid arm.  On both arms.  Did not itch.  Lasted 2 -3 days. Dull headache with dizziness for about a week.
He felt like fainting; He experienced weakness; A spontaneous report was received from consumer concerning a 65 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and  experienced weakness, he felt like fainting.  The patient's medical history was not reported by the reporter. Concomitant medications taken by the patient was not provided.   On an unknown date, prior to the onset of the event, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) through intramuscular route on left arm for prophylaxis of COVID-19 infection.  On an unknown date, on the same day of vaccination, patient experienced weakness and felt like fainting. The symptoms were subsided. Patient had not received any treatment for his symptoms and was not on any medications.  Treatment activities for event was not taken.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events,  weakness and felt like fainting were resolved.; Reporter'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.
injection site is red; injection site swollen; injection site hot to the touch; This case was reported by a consumer via interactive digital media SHINGRIX and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2021 09:30, the patient received the 1st dose of Shingrix. In August 2021, 33 hrs after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The reporter stated that, the patient received the 1st dose of Shingrix vaccination the day before reporting date at 9:30 am and 33hours after the vaccination the patient's injection site was very hot to the touch. The patient also experienced red and swollen injection site. The reporter stated that the events did not worry him/her and asked could he/she ice that area.
Rash hives itching -4 hours after receiving second dose.  Covid arm-swollen left arm  up into shoulder and under arm pain and tingling down entire arm-48 hours after 2nd dose Loose stool -6 days after 2nd dose   Taking 10mg steroids 2 times daily and extra strength Tylenol  will follow up with PCP 10/14/21