chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd DTP/HIB/HEP around 7PM on 6MAY92 & around 1130PM pt jerky, shaking, cold, clammy; pt taken to ER vs stable BP 120/80, HR 180, p-40, t100.8; examined by ER MD felt viral;
Moderna COVID-19 - Symptoms included: headache, muscle pain, joint pain, chills, nausea, low grade fever 0f 100.0 F, and fatigue
pt recvd vax 1NOV95 & 6NOV95 pt exp 3 episodes of vomiting, 100.8 temp, dizziness, & dehydration marked by an inc heart rate, two second prolonged capillary refill & refill & weight loss-presented to MD & hospitalized x 2 days;
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: pt passed out for 10 seconds, blood pressure low, when he regained consciouness he vomited.Recovered in about a half hour.
Pt received vaccine 7/19/99 and subsequently developed an injection site reaction characterized by pain and swelling.
Arm is still sore; Injection site still red; Injection site still swollen; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is still sore), INJECTION SITE ERYTHEMA (Injection site still red), INJECTION SITE SWELLING (Injection site still swollen) and HEADACHE (Headaches) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is still sore), INJECTION SITE ERYTHEMA (Injection site still red), INJECTION SITE SWELLING (Injection site still swollen) and HEADACHE (Headaches). At the time of the report, VACCINATION SITE PAIN (Arm is still sore), INJECTION SITE ERYTHEMA (Injection site still red), INJECTION SITE SWELLING (Injection site still swollen) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.
This spontaneous report as received from a registered nurse refers to a 19 year old female patient with no drug reactions/allergies. The patient received the RECOMBIVAX HB (lot number and expiry date were not reported) series as follows: first dose 0.5 milliliter (ml) intramuscularly on 06-JUL-1993, second dose 0.5 ml intramuscularly on 06-AUG-1993 (reported as four weeks after the first dose), and the third dose 0.5 ml intramuscularly approximately on an unknown date in 1995 (reported as when the patient was 2 years old). Concomitant medication was none. On 24-MAY-2013, titers were drawn on the patient for school purpose and the results of the titers were negative. The patient sought medical attention (contacted the physician's office). No treatment was given. The outcome of the event titers were negative was unknown. Additional information has been requested.
No Adverse Event; HCP called to report a TE with PROQUAD.  Improperly stored. TE case reference 02490108.  No adverse effects reported.  Consent to contact is no. No additional AE/No PQC. AE cross reference cases 02490153, 02490133, 02490163, 02490160, 02490148, 02490; This spontaneous report was received from an other health care professional refers to a 4-year-old patient of unknown gender.     The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-AUG-2023, the patient was vaccinated with the dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin)(PROQUAD) lot #W029555, expiration date: 14-MAR-2024, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis.         Administered dose of vaccine experienced the temperature excursion (product storage error). The information about previous temperature excursion were not provided. There were no additional adverse events reported (no adverse event).
5NOV94 2PM had severe h/a, t101 x 1 day, swollen eyes & puffy face, erythematous macular rash @ elbow joint & on knuckles of index & middle fingers of rt hand; also had aches & pains all over;
Started to feel sick almost immediately, felt dizzy and lightheaded. Left arm painful and stinging at times. Began to have very sharp pains in joints running all the way down to feet. Very bad headache (and I never get headaches), interfering with my schoolwork, sleep, and work. Tried to work but very fatigued and tired whereas normally I am very energetic. Had to take constant breaks at work. At home couldn't concentrate, read or write very well due to extreme headache. Started to feel sick to my stomach and like I was going to vomit. As I am typing this now I feel lightheaded, have a horrible headache, and feel like I am going to throw up constantly. Before I got the flu shot I was fine, healthy, energetic, could walk for hours. I am afraid of what will happen if these symptoms do not go away or worsen as I have to work tomorrow and I am in college. I have been taking vitamins and drinking tea with antioxidants to try to help but it's not really doing much for me.
Initial light headedness about 15-20 mins after receiving vaccine. After about 30 minutes, I became dizzy and very disoriented to the point that thinking clearly and standing was difficult. After one hour, the disorientation/dizziness subsided and chills occurred for about 45 minutes. All symptoms had subsided about 1.5 hours after receiving vaccine.
Painful; Red; Swollen; Could not bend my arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a 77-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Painful), erythema (Verbatim: Red), swelling (Verbatim: Swollen) and movement disorder (Verbatim: Could not bend my arm). The outcome of the pain, erythema, swelling and movement disorder were resolved (duration 4 days).   It was unknown if the reporter considered the pain, erythema, swelling and movement disorder to be related to Shingles vaccine.     It was unknown if the company considered the pain, erythema, swelling and movement disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine at age of 62 years and now he or she was 77 years old and fortunately he or she did not had shingles. The reporter reported that he or she was glad for received shingles vaccine but it was most painful afterwards. The patient experienced pain, red, swollen and could not bend his or her arm for four days. The reporter stated that he or she never had a reaction like that with any vaccine. Follow-up would not possible as no contact details were available.
Had the vaccine booster on Wednesday.  Within a few hours, I had a migraine headache with pain in my left shoulder and neck.  I was not able to drive home because I became so sleepy.  When I did get home, I went to bed at 7:30 pm and basically didn't get up until 4:30 am this morning (Friday).   I had SEVERE chills.  I would almost call them confusions.  My chest and back muscles would contract so hard that my whole body would shake.  My teeth were chattering.   This was followed by a fever that reached 102 and I took tylenol.  Over the next day, these two things would contine.  Severe chills and fever.   I couldn't eat.  I couldn't drink.  I couldn't watch tv or read a book.  All I could do was either sleep or sit in a chair staring out into space.  Even today, my mind is not very clear.   Today I also have a constant need to pee.  Even after I basically haven't had much water or any other liquid since Wednesday.  After my 2nd shot, also Pfizer, I had very similar side effects but not as severe.   Today, right now, Friday, 11/19/21 at 3:00 pm my temperature is 101.2.
The next day her left arm was swollen from elbow to armpit. It was red, swollen, hot and very tender. Pt was unable to lift arm or have anything touch it. Pt had body aches and temp got to 102. Pt called today to report and arm is better. Arm is still tender, redness has gone down, swelling is down. Better today 10/14/14.
Nausea, bad headache, dizziness, muscle aches; Swelling at site.
missed their second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed their second dose) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed their second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed their second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.   Reporter did not allow further contact
Patient is a healthcare worker who received the COVID-19 vaccine (Pfizer).  Within 1 hour of vaccine, patient began experiencing nasal passage tightness, nasal congestion, and facial numbness. No wheezing, rash, visible swelling, tachycardia, or hypotensions.  Given diphenhydramine, famotidine, and prednisone in emergency department.  During observation in ED, started having throat and chest tightness with hyperventilation.  This improved with lorazepam.  Patient felt improved and was discharged with Epi pen and told to follow-up with her allergist.
wrong vaccine given; child (4 years old) received a  Boostrix dose; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 575HC, expiry date 28th February 2023) for prophylaxis.   On 27th August 2021, the patient received Boostrix (intramuscular). On 27th August 2021, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The health care professional reported that, the 4 years old patient received a Boostrix dose instead of an Infanrix dose in the right thigh, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The reporter transferred to medical informer for further assistance. The reporter consented to follow up. The reporter gave permission to contact from GlaxoSmithKline. The case had been link with US2021156430, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021156430:same reporter
Information has been received from a physician concerning a teenage female who on 04 Dec 2006 was vaccinated with the second dose of Gardasil (lot#653736/0868F), IM injection. Concomitant medication was not reported. On 05 Dec 2006, the patient developed a rash on her forearms. The physician reported that the patient was seen by another physician in the office, who prescirbed Benadryl to treat the rash. The outcome of the event was not reported. Additional information has been requested.
feeling dizzy; throwing up; generally feeling horrible; This is a spontaneous report from contactable consumer. This is a male consumer (patient) reported for himself.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch Number was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 Immunisation. Medical history and concomitant medications were not reported. On an unspecified date (after vaccination), the patient experienced feeling dizzy, throwing up and generally feeling horrible after receiving his first dose. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
unable to use left arm; This case was reported by a consumer and described the occurrence of upper extremity dysfunction in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced upper extremity dysfunction. On an unknown date, the outcome of the upper extremity dysfunction was not recovered/not resolved.   It was unknown if the reporter considered the upper extremity dysfunction to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-DEC-2022 Reporter's Comment: The reporters husband had a Shingrix shot 3 months prior to the reporting that had left him unable to use his left arm. The reporter wanted to know did you offered support in this situation.
Per Maternal Grandmother large flat patches to face, armpits and trunk started AM on 6/13/14 was taken to PCP, sent home with Claritin.  On 6/23/14 Fine papular rash to chest, face and back, went back to PCP where they were told it looks like varicella.
2pm: I was asked to assess pt; pt c/o difficulty swallowing "something stuck in my throat", difficAfter incident pt stated she had immediate LBP and nausea after injection; staff not aware initallyulty "catching my breath", and generalized numbness over body. Lungs CTA, AP 76 RRR, resp 20. BP 131/97. Pt sl pale. Pt crying; fists clenched. Talked with her to help calm her; symptoms persist. She denies +PMH except hx of COVID-19 illness 2:05pm: Call placed to Dr., medical director indicated in protocol binder. LVM with brief description of situation. He returned call at 2:35pm and plan reviewed. 2:09pm: Symptoms persist. Epinephrine 0.3mg given IM RD. Explained purpose of epinephrine to pt. Pt states symptoms improving but still present. 2:16pm: BP 140/107; radial pulse 93. 2:24pm: Symptoms persist but improved per pt; still feels difficulty catching breath and sensation of something stuck in throat. 2nd dose of epinephrine 0.3mg given IM LD. 2:29pm: BP 138/91; radial pulse 98, resp 16 even and unlabored. Numbness of legs resolved; other symptoms persist. 2:30pm EMS activated due to persistent symptoms. Call placed by staff. 2:35pm: BP 134/89, radial pulse 95; resp 16 even and unlabored. 2:45 pm: EMS here; verbal report given; written synopsis given. Pt transported to local hospital. Concentra staff- - aware of situation.
Shingles like rash; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of nausea (For tolerance to 1st dose please refer case US2019007963 ).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a shingles like rash for the 2nd day at the date of reporting. The patient wanted to get detailed information about possible shingles after vaccine.
This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 6-year-old male patient who received FLULAVAL QUADRIVALENT (batch number Y7X9Z, expiry date 30th April 2017). In September 2016, the patient received FLULAVAL QUADRIVALENT. On an unknown date, 1 day after receiving FLULAVAL QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb, injection site warmth and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site warmth were recovered/resolved and the outcome of the injection site erythema was unknown. The reporter considered the extensive swelling of vaccinated limb, injection site warmth and injection site erythema to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The patient experienced warm, raised, red areas in around the injection site. The injection site reactions extended from shoulder to elbow, which led to extensive swelling of vaccination limb. In about 2 days all events were resolved without further medical attention. The health care professional stated that no other vaccines were administered on the same day. The reported lot number (Y7X92) for FLULAVAL QUADRIVALENT did not exist and was updated to Y7X9Z, according to sales database. No further information was provided. This case was one of the 4 cases, reported by same reporter.
This case was reported in a literature article and described the occurrence of anaphylaxis in a subject who received Meningococcal ACWY-CRM vaccine. On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and other: Serious per reporter. The subject was treated with epinephrine. The outcome of anaphylaxis was unknown. It was unknown if the investigator considered the anaphylaxis to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of anaphylaxis in a patient of aged between 0-89 years of unspecified gender who was vaccinated with unspecified meningococcal A, C, W, Y vaccine (manufacturer unknown). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. No information on patient's medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified meningococcal A,C,W,Y vaccine (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (32), Tdap (776) and HPV (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, an unknown period after vaccination, the patient developed anaphylaxis. The case did not meet the definition of Brighton criteria. In this study, 5 of the 9 cases of anaphylaxis reported symptom onset within 30 min of vaccination 2 reported median onset interval of symptoms between 0-1 days). This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). The patient was treated with epinephrine. The outcome of the event was not reported. The authors did not comment on the relationship between the event anaphylaxis related to unspecified meningococcal A,C,W,Y vaccine. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Felt warmth to area of injection site RUA and redness with tenderness on first night with neck ache; noticed increased size of redness and warmth and tenderness to upper arm; by 3rd day, now feeling achiness radiating to R hand; taken Benadryl and ibuprofen for symptoms, ice packs applied.
At 10:58 am patient stated "I feel like I'm going to pass out". EMS called. At 11:02 am patient stated "I feel faint" & c/o nausea and a "humming sensation" at bilateral ears. Applied cool compresses and monitored until EMS arrived at 11:14 am. Patient transported to local ER by EMS. Vital signs stable.
fever, nausea, vomiting, headaches, muscle aches, lymphadenopathy, coughing, malaise fluids, rest, ibuprofen, Ultracet
severe joint pain, swelling, disabling symptoms with generalized malaise (mostly wrists and hands).  Most severe malaise for 7-10 days, not able to get out of bed, but joints symptoms not resolving for more than 6 months.
Case number PHEH2016US026579, is an initial spontaneous report received from a consumer on 11 Oct 2016. This report refers to a 62 years old female patient. Medical history and concomitant medications were not reported. Current conditions included could not exercise or perform other activities. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 10 Sep 2016. On the same day after vaccination, the patient experienced extreme sore arm right after she received vaccine. It was reported that, till date, her arm was sore and she could not exercise or perform other activities due to pain in her arm. The outcome of the event sore arm was reported as condition unchanged. The seriousness of the event sore arm was reported as non serious by the consumer. The causality of the event was not reported. The case was lost to follow up at initial.
Loss of sense of balance, walking difficulty, brain fog, tiredness, backache, heartburn like stomach pain, skin rash, loss of (head)hair.
awoke 16OCT92 w/rash, lethargy, flushed appearance afebrile exam otherwise nl;
p/vax pt fell to floor w/jerking motion which appeared to be a sz c/o nausea & feeling hot, cold compress applied;BP 90/60;placed on chair;exam per MD bottom lip swollen;EEG ordered to r/o sz disorder;
I have been sick.; Light-headed/ Dizzy; Vomiting; Diarrhea; I had a really bad headache,  Had it for 4 days.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated, got the Pfizer shot Sunday. Sunday was fine but ever since Monday, consumer have been sick. Went to the doctor and to urgent care and did not know what else to do. Consumer also stated, lightheaded, vomiting., diarrhea and had a really bad headache had it for 4 days. The outcome for the event headache was recovered on an unspecified date whereas outcome for the other events were unknown.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].
Muscle soreness greater than 1 month post administration with pain intensifying when limb is hyper flexed. Stated that it is however slowly getting better.